Adrenocortical carcinoma · NCT05286814
PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
- Status
- RECRUITING (ClinicalTrials.gov)
- Phase
- PHASE2
- Sponsor
- National Cancer Institute (NCI)
- Registry records
- CTGOV NCT05286814 (RECRUITING)Registry last updated 2026-10-16
Eligibility, line by line
| Verdict | In plain words (machine summary) | Registry text, verbatim | If unmet |
|---|---|---|---|
| inclusion inclusion · condition · confidence 0.95 | Participants must have a documented diagnosis of one of the following cancers: Metastatic colorectal cancer (mCRC), Intrahepatic cholangiocarcinoma (ICC), Adrenocortical carcinoma (ACC) with liver dominant disease | "Participants must have a documented diagnosis of one of the following cancers:" | |
| inclusion inclusion · condition · confidence 0.90 | Adrenocortical carcinoma (ACC) with liver dominant disease | "Adrenocortical carcinoma (ACC) with liver dominant disease" | |
| inclusion inclusion · logistics · confidence 0.30 | Participants must have an identified medical oncologist who has recommended and is planning to oversee treatment with one of the following standard chemotherapy regimens (based on disease type) not to begin sooner than 28 days after initiation of study-directed HAIP intervention | "Participants must have an identified medical oncologist who has recommended and is planning to oversee treatment with one of the following standard chemotherapy regimens (based on disease type) not to begin sooner than 28 days after initiation of study-directed HAIP intervention:" | |
| inclusion inclusion · age sex · confidence 0.98 | Age >= 18 years. | "Age \>= 18 years." | |
| inclusion inclusion · pregnancy contraception · confidence 0.30 | Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP). | "Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP)." | |
| inclusion inclusion · pregnancy contraception · confidence 0.30 | All participants (regardless of childbearing potential) must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study treatment for those able to father a child or 6 months after completion of study treatment for those of child-bearing potential | "All participants (regardless of childbearing potential) must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study treatment for those able to father a child or 6 months after completion of study treatment for those of child-bearing potential" | |
| inclusion inclusion · pregnancy contraception · confidence 0.30 | Nursing (including breastfeeding) participants must agree to discontinue nursing. | "Nursing (including breastfeeding) participants must agree to discontinue nursing." | |
| inclusion inclusion · other · confidence 0.30 | Arterial anatomy on CT angiogram or CT chest, abdomen and pelvis multiphase amenable to placement of the HAIP. | "Arterial anatomy on CT angiogram or CT chest, abdomen and pelvis multiphase (i.e., CT C/A/P multiphase) amenable to placement of the HAIP." | |
| inclusion inclusion · consent · confidence 0.30 | Participant must sign the informed consent form to participate in this study. | "Participant must sign the informed consent form to participate in this study." | |
| inclusion inclusion · comorbidity · confidence 0.30 | HIV-positive participants may be considered for this study only if they have an undetectable viral load. | "HIV-positive participants may be considered for this study only if they have an undetectable viral load." | |
| inclusion inclusion · logistics · confidence 0.30 | Participants must agree to co-enroll on the Surgical Oncology Program's tissue collection protocol 13C0176. | "Participants must agree to co-enroll on the Surgical Oncology Program s tissue collection protocol 13C0176" | |
| inclusion inclusion · stage extent · confidence 0.85 | Participant's liver metastases must not be amenable to resection/ablation to No Evidence of Disease (NED) in one stage. | "Participant's liver metastases must not be amenable to resection/ablation to No Evidence of Disease (NED) in one stage." | |
| inclusion inclusion · condition · confidence 0.95 | Participants must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma metastatic to the liver (Cohort 1). | "Participants must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma metastatic to the liver (Cohort 1)." | |
| inclusion inclusion · lesion burden · confidence 0.95 | Participants must have measurable liver metastatic disease. | "Participants must have measurable liver metastatic disease." | |
| inclusion inclusion · prior therapy · confidence 0.95 | Participants must have received 1st line systemic chemotherapy. | "Participants must have received 1st line systemic chemotherapy." | |
| inclusion inclusion · performance status · confidence 0.97 | ECOG performance status <= 1. | "ECOG performance status \<= 1." | |
| inclusion inclusion · lab value · confidence 0.97 | leukocytes > 3,000/mcL | "leukocytes \> 3,000/mcL" | |
| inclusion inclusion · lab value · confidence 0.97 | absolute neutrophil count > 1,500/mcL | "absolute neutrophil count \> 1,500/mcL" | |
| inclusion inclusion · lab value · confidence 0.97 | platelets > 90,000/mcL | "platelets \> 90,000/mcL" | |
| inclusion inclusion · lab value · confidence 0.97 | hemoglobin > 8 g/dL | "hemoglobin \> 8 g/dL" | |
| inclusion inclusion · lab value · confidence 0.97 | total bilirubin < 1.5 X institutional upper limit of normal | "total bilirubin \< 1.5 X institutional upper limit of normal" | |
| inclusion inclusion · lab value · confidence 0.97 | AST(SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal | "AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal" | |
| inclusion inclusion · lab value · confidence 0.85 | creatinine within normal institutional limits OR eGFR within normal as predicted by the CKD-EPI equation > 60 mL/min/1.73 m2. | "creatinine within normal institutional limits OR eGFR within normal as predicted by the CKD-EPI equation \> 60 mL/min/1.73 m2." | |
| inclusion inclusion · condition · confidence 0.95 | Participants must have histologically or cytologically confirmed diagnosis of intrahepatic cholangiocarcinoma confined to the liver (Cohort 2). | "Participants must have histologically or cytologically confirmed diagnosis of intrahepatic cholangiocarcinoma confined to the liver (Cohort 2)." | |
| inclusion inclusion · logistics · confidence 0.30 | Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required. | "Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required." | |
| inclusion inclusion · stage extent · confidence 0.30 | Clinical or radiographic evidence of metastatic disease to regional (porta hepatis) lymph nodes will be allowed, provided it is amenable to resection. | "Clinical or radiographic evidence of metastatic disease to regional (porta hepatis) lymph nodes will be allowed, provided it is amenable to resection." | |
| inclusion inclusion · lesion burden · confidence 0.95 | Participants must have radiographically measurable disease. | "Participants must have radiographically measurable disease." | |
| inclusion inclusion · stage extent · confidence 0.95 | Disease must be considered unresectable at the time of preoperative evaluation. | "Disease must be considered unresectable at the time of preoperative evaluation." | |
| inclusion inclusion · prior therapy · confidence 0.95 | Participants must have received 1st line systemic chemotherapy. | "Participants must have received 1st line systemic chemotherapy." | |
| inclusion inclusion · performance status · confidence 0.97 | ECOG performance status <=1. | "ECOG performance status \<=1." | |
| inclusion inclusion · lab value · confidence 0.97 | leukocytes >= 2,000/ mm^3 | "leukocytes \>= 2,000/ mm\^3" | |
| inclusion inclusion · lab value · confidence 0.97 | absolute neutrophil count > 1,500/mcL | "absolute neutrophil count \> 1,500/mcL" | |
| inclusion inclusion · lab value · confidence 0.97 | platelets >= 75,000/ mm^3 | "platelets \>= 75,000/ mm\^3" | |
| inclusion inclusion · lab value · confidence 0.97 | hemoglobin > 8 g/dL | "hemoglobin \> 8 g/dL" | |
| inclusion inclusion · lab value · confidence 0.97 | total bilirubin < 1.5 mg/dl | "total bilirubin \< 1.5 mg/dl" | |
| inclusion inclusion · lab value · confidence 0.97 | creatinine <= 1.5 mg/dl | "creatinine \<= 1.5 mg/dl" | |
| inclusion inclusion · condition · confidence 0.95 | Participants must have histologically or cytologically confirmed diagnosis of adrenocortical carcinoma (ACC) | "Participants must have histologically or cytologically confirmed diagnosis of adrenocortical carcinoma (ACC)" | |
| inclusion inclusion · prior therapy · confidence 0.95 | Participants must have received at least one line of systemic chemotherapy. | "Participants must have received at least one line of systemic chemotherapy." | |
| inclusion inclusion · lesion burden · confidence 0.95 | Participants must have measurable liver metastatic disease. | "Participants must have measurable liver metastatic disease." | |
| inclusion inclusion · performance status · confidence 0.97 | ECOG performance status <= 1. | "ECOG performance status \<= 1." | |
| inclusion inclusion · lab value · confidence 0.97 | leukocytes > 3,000/mcL | "leukocytes \> 3,000/mcL" | |
| inclusion inclusion · lab value · confidence 0.97 | absolute neutrophil count > 1,500/mcL | "absolute neutrophil count \> 1,500/mcL" | |
| inclusion inclusion · lab value · confidence 0.97 | platelets > 90,000/mcL | "platelets \> 90,000/mcL" | |
| inclusion inclusion · lab value · confidence 0.97 | hemoglobin > 8 g/dL | "hemoglobin \> 8 g/dL" | |
| inclusion inclusion · lab value · confidence 0.97 | total bilirubin < 1.5 X institutional upper limit of normal | "total bilirubin \< 1.5 X institutional upper limit of normal" | |
| inclusion inclusion · lab value · confidence 0.97 | AST(SGOT)/ALT(SGPT) < 3 X institutional upper limit of normal | "AST(SGOT)/ALT(SGPT) \< 3 X institutional upper limit of normal" | |
| inclusion inclusion · lab value · confidence 0.97 | creatinine < 2 X institutional upper limit of normal | "creatinine \< 2 X institutional upper limit of normal" | |
| exclusion exclusion · prior therapy · confidence 0.95 | Participants who are receiving any other investigational agents. | "Participants who are receiving any other investigational agents." | |
| exclusion exclusion · prior therapy · confidence 0.97 | Participants who have previously received rIL-12. | "Participants who have previously received rIL-12." | |
| exclusion exclusion · comorbidity · confidence 0.93 | Participants with active autoimmune diseases, that might deteriorate when receiving an immunostimulatory agent (with exceptions) | "Participants with active autoimmune diseases, that might deteriorate when receiving an immunostimulatory agent with the exceptions:" | |
| exclusion exclusion · comorbidity · confidence 0.93 | History of organ transplant, except for transplants that do not require immunosuppression. | "History of organ transplant, except for transplants that do not require immunosuppression." | |
| exclusion exclusion · comorbidity · confidence 0.95 | History of or active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis). | "History of or active inflammatory bowel disease (e.g., Crohn s disease, ulcerative colitis)." | |
| exclusion exclusion · comorbidity · confidence 0.92 | Known hypersensitivity or allergic reactions attributed to compounds of similar composition to the study medication, such as recombinant IL-12 or other monoclonal antibodies, and history of allergic reactions to compounds similar to FUDR or heparin. | "Known hypersensitivity or allergic reactions attributed to any compounds of similar chemical or biologic composition to the study medication, such as recombinant IL-12 or other monoclonal antibodies and history of allergic reactions attributed to compounds of similar chemical composition to FUDR or heparin." | |
| exclusion exclusion · comorbidity · confidence 0.95 | Clinically significant (i.e., active) cardiovascular disease: stroke < 6 months, myocardial infarction < 6 months, unstable angina, CHF >= NYHA III or serious cardiac arrhythmia requiring medication. | "Clinically significant (i.e., active) cardiovascular disease" | |
| exclusion exclusion · comorbidity · confidence 0.90 | All conditions associated with significant necrosis of nontumor-bearing tissues. | "All conditions associated with significant necrosis of nontumor-bearing tissues." | |
| exclusion exclusion · comorbidity · confidence 0.93 | Esophageal or gastroduodenal ulcers < 6 months prior to treatment. | "Esophageal or gastroduodenal ulcers" | |
| exclusion exclusion · comorbidity · confidence 0.95 | Active ischemic bowel disease. | "Active ischemic bowel disease." | |
| exclusion exclusion · comorbidity · confidence 0.30 | Psychiatric illness/social situations that would limit compliance with study requirements. | "Psychiatric illness/social situations that would limit compliance with study requirements." | |
| exclusion exclusion · comorbidity · confidence 0.93 | Active concurrent malignancies within the last five years other than colorectal primary except basal cell skin carcinoma and thyroid carcinoma. | "Active concurrent malignancies within the last five years other than colorectal primary except basal cell skin carcinoma and thyroid carcinoma." | |
| exclusion exclusion · prior therapy · confidence 0.95 | Prior radiation to liver. | "Prior radiation to liver." | |
| exclusion exclusion · comorbidity · confidence 0.97 | Participants with active Hepatitis B or C infection. | "Participants with active Hepatitis B or C infection." | |
| exclusion exclusion · comorbidity · confidence 0.88 | Significant acute or chronic infections (i.e., tuberculosis) history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings). | "Significant acute or chronic infections (i.e., tuberculosis)" | |
| exclusion exclusion · other · confidence 0.30 | Any condition, including the presence of laboratory abnormalities and/or insufficient normal liver parenchyma, which places the participant at unacceptable risk or confounds interpretation of study data. | "Any condition, including the presence of laboratory abnormalities and/or insufficient normal liver parenchyma, which places the participant at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study." | |
| exclusion exclusion · stage extent · confidence 0.30 | Participants with incontrovertible radiographic evidence of disease outside of the colon/rectum (primary) and liver given unlikelihood of benefit from liver-directed therapy (with exception for limited small lung lesions). | "Participants with incontrovertible radiographic evidence of disease outside of the colon/rectum (primary) and liver given unlikelihood of benefit from liver-directed therapy." | |
| exclusion exclusion · prior therapy · confidence 0.30 | Participants who have undergone extra-hepatic metastasectomy and have a documented disease-free interval less than or equal to 4 months. | "Participants who have undergone extra-hepatic metastasectomy and have a documented disease-free interval less than or equal to 4 months." | |
| exclusion exclusion · biomarker · confidence 0.90 | Participants with a history of MSI-high results who need to be treated with check-point inhibitors. | "Participants with a history of MSI-high results who need to be treated with check-point inhibitors." | |
| exclusion exclusion · prior therapy · confidence 0.97 | Prior treatment with FUDR. | "Prior treatment with FUDR." | |
| exclusion exclusion · stage extent · confidence 0.90 | Presence of distant metastatic disease. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection. | "Presence of distant metastatic disease." | |
| exclusion exclusion · prior therapy · confidence 0.97 | Prior treatment with FUDR. | "Prior treatment with FUDR." | |
| exclusion exclusion · comorbidity · confidence 0.97 | Diagnosis of sclerosing cholangitis. | "Diagnosis of sclerosing cholangitis." | |
| exclusion exclusion · comorbidity · confidence 0.95 | Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). | "Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis)." | |
| exclusion exclusion · stage extent · confidence 0.30 | Participants with incontrovertible radiographic evidence of additional abdominal disease outside of the liver (including the primary tumor) that is not amenable to complete surgical extirpation at the time of pump placement. | "Participants with incontrovertible radiographic evidence of additional abdominal disease outside of the liver (including the primary tumor) that is not amenable to complete surgical extirpation at the time of pump placement." | |
| exclusion exclusion · comorbidity · confidence 0.95 | Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). | "Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis)." | |
| exclusion exclusion · comorbidity · confidence 0.97 | Diagnosis of sclerosing cholangitis. | "Diagnosis of sclerosing cholangitis." | |
| exclusion exclusion · stage extent · confidence 0.85 | Participants with pulmonary metastases that have progressed by RECIST criteria in the preceding 3 months prior to study enrollment. | "Participants with pulmonary metastases that have progressed by RECIST criteria in the preceding 3 months prior to study enrollment." | |
| exclusion exclusion · biomarker · confidence 0.88 | Participants with known mismatch repair mutation who have not been treated with a checkpoint inhibitor. | "Participants with known mismatch repair mutation who have not been treated with a checkpoint inhibitor." |
Criteria extracted by claude-sonnet-5-5; 0 extracted quotes rejected for not matching the registry text.
Full eligibility text as the registry publishes it
* INCLUSION CRITERIA: Inclusion Criteria- All Cohorts * Participants must have a documented diagnosis of one of the following cancers: * Metastatic colorectal cancer (mCRC) * Intrahepatic cholangiocarcinoma (ICC) * Adrenocortical carcinoma (ACC) with liver dominant disease * Participants must have an identified medical oncologist who has recommended and is planning to oversee treatment with one of the following standard chemotherapy regimens (based on disease type) not to begin sooner than 28 days after initiation of study-directed HAIP intervention: * mCRC: FOLFOX or FOLFIRI * ICC: GemOx or FOLFOX * ACC: GemOx * Age \>= 18 years. * Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP). NOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. IOCBP must have a negative pregnancy test (HCG blood or urine) during screening. * All participants (regardless of childbearing potential) must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 3 months after completion of study treatment for those able to father a child or 6 months after completion of study treatment for those of child-bearing potential (i.e., IOCBP). Highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence. Note: The use of condoms by participants who are able to get other individuals pregnant is required unless the partner of childbearing potential is permanently sterile. * Nursing (including breastfeeding) participants must agree to discontinue nursing. * Arterial anatomy on CT angiogram or CT chest, abdomen and pelvis multiphase (i.e., CT C/A/P multiphase) amenable to placement of the HAIP. * Participant must sign the informed consent form to participate in this study. * HIV-positive participants may be considered for this study only if they have an undetectable viral load. * Participants must agree to co-enroll on the Surgical Oncology Program s tissue collection protocol 13C0176, "Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors". * Participant's liver metastases must not be amenable to resection/ablation to No Evidence of Disease (NED) in one stage. Inclusion Criteria-Metastatic Colorectal Carcinoma * Participants must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma metastatic to the liver (Cohort 1). * Participants must have measurable liver metastatic disease. * Participants must have received 1st line systemic chemotherapy. * ECOG performance status \<= 1. * Participants must have adequate organ and marrow function as defined below: * leukocytes \> 3,000/mcL * absolute neutrophil count \> 1,500/mcL * platelets \> 90,000/mcL * hemoglobin \> 8 g/dL * total bilirubin \< 1.5 X institutional upper limit of normal * AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal * creatinine within normal institutional limits OR eGFR within normal as predicted by the CKD-EPI equation \> 60 mL/min/1.73 m2. Inclusion Criteria-Intrahepatic Cholangiocarcinoma * Participants must have histologically or cytologically confirmed diagnosis of intrahepatic cholangiocarcinoma confined to the liver (Cohort 2). Archival tumor sample may be used but if archival tissue is not available or is not adequate, tissue biopsy will be required. * Clinical or radiographic evidence of metastatic disease to regional (porta hepatis) lymph nodes will be allowed, provided it is amenable to resection. * Participants must have radiographically measurable disease. * Disease must be considered unresectable at the time of preoperative evaluation. * Participants must have received 1st line systemic chemotherapy. * ECOG performance status \<=1. * Participants must have adequate organ and marrow function as defined below: * leukocytes \>= 2,000/ mm\^3 * absolute neutrophil count \> 1,500/mcL * platelets \>= 75,000/ mm\^3 * hemoglobin \> 8 g/dL * total bilirubin \< 1.5 mg/dl * creatinine \<= 1.5 mg/dl Inclusion Criteria-Adrenocortical Carcinoma * Participants must have histologically or cytologically confirmed diagnosis of adrenocortical carcinoma (ACC), also referred to as "adrenocortical cancer". * Participants must have received at least one line of systemic chemotherapy. * Participants must have measurable liver metastatic disease. * ECOG performance status \<= 1. * Participants must have adequate organ and marrow function as defined below: * leukocytes \> 3,000/mcL * absolute neutrophil count \> 1,500/mcL * platelets \> 90,000/mcL * hemoglobin \> 8 g/dL * total bilirubin \< 1.5 X institutional upper limit of normal * AST(SGOT)/ALT(SGPT) \< 3 X institutional upper limit of normal * creatinine \< 2 X institutional upper limit of normal EXCLUSION CRITERIA: Exclusion Criteria- All Cohorts Participants who are receiving any other investigational agents. * Participants who have previously received rIL-12. * Participants with active autoimmune diseases, that might deteriorate when receiving an immunostimulatory agent with the exceptions: * diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible; * participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses \<= 10 mg of prednisone or equivalent per day; * administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is eligible. * History of organ transplant, except for transplants that do not require immunosuppression. * History of or active inflammatory bowel disease (e.g., Crohn s disease, ulcerative colitis). * Known hypersensitivity or allergic reactions attributed to any compounds of similar chemical or biologic composition to the study medication, such as recombinant IL-12 or other monoclonal antibodies and history of allergic reactions attributed to compounds of similar chemical composition to FUDR or heparin. * Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke \< 6 months prior to enrollment, myocardial infarction \< 6 months prior to enrollment, unstable angina, congestive heart failure (\>= NYHA III) or serious cardiac arrhythmia requiring medication. * All conditions associated with significant necrosis of nontumor-bearing tissues. * Esophageal or gastroduodenal ulcers \< 6 months prior to treatment. * Active ischemic bowel disease. * Psychiatric illness/social situations that would limit compliance with study requirements. * Active concurrent malignancies within the last five years other than colorectal primary except basal cell skin carcinoma and thyroid carcinoma. * Prior radiation to liver. * Participants with active Hepatitis B or C infection. * Significant acute or chronic infections (i.e., tuberculosis) history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings). * Any condition, including the presence of laboratory abnormalities and/or insufficient normal liver parenchyma, which places the participant at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study. Exclusion Criteria-Metastatic Colorectal Carcinoma -Participants with incontrovertible radiographic evidence of disease outside of the colon/rectum (primary) and liver given unlikelihood of benefit from liver-directed therapy. Note: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminant as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy. * Participants who have undergone extra-hepatic metastasectomy and have a documented disease-free interval less than or equal to 4 months. * Participants with a history of MSI-high results who need to be treated with check-point inhibitors. * Prior treatment with FUDR. Exclusion Criteria-Intrahepatic Cholangiocarcinoma -Presence of distant metastatic disease. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection. Note: Lung lesions seen on CT do not always represent metastases. They are very hard to qualify, therefore exception to this exclusion is participants with fewer than five lung lesions greater than 1 cm that have not increased in size by more than 10% over a 4-month period of time and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 cm are indeterminate as far as etiology is concerned and will be ignored. Participants with liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5 amenable to thoracoscopic removal) are still likely to benefit from liver directed therapy. * Prior treatment with FUDR. * Diagnosis of sclerosing cholangitis. * Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). Exclusion Criteria-Adrenocortical Carcinoma * Participants with incontrovertible radiographic evidence of additional abdominal disease outside of the liver (including the primary tumor) that is not amenable to complete surgical extirpation at the time of pump placement. * Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). * Diagnosis of sclerosing cholangitis. * Participants with pulmonary metastases that have progressed by RECIST criteria in the preceding 3 months prior to study enrollment. * Participants with known mismatch repair mutation who have not been treated with a checkpoint inhibitor. Acceptable methods of MSI testing for history of MSI results include immunohistochemistry (IHC) and next generation sequencing (NGS) of tumor material.
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