Adrenocortical carcinoma · NCT06683846
Ivonescimab in the Treatment of Multiple Advanced Tumors
Ivonescimab (PD-1/VEGF Bispecpecial Antibody) in the Treatment of Multiple Advanced Tumors: a Multi-cohort, Multi-center, Single-arm Phase II Study
- Status
- RECRUITING (ClinicalTrials.gov)
- Phase
- PHASE2
- Sponsor
- Fudan University
- Registry records
- CTGOV NCT06683846 (RECRUITING)Registry last updated 2025-08-24
Eligibility, line by line
| Verdict | In plain words (machine summary) | Registry text, verbatim | If unmet |
|---|---|---|---|
| inclusion inclusion · consent · confidence 0.30 | Individuals able to understand and give written informed consent. | "Individuals able to understand and give written informed consent." | |
| inclusion inclusion · condition · confidence 0.95 | Histologically or cytologically confirmed cancer of one of the following types: Paget's disease of scrotum with infiltrating sweat gland carcinoma, paraganglioma, pheochromocytoma, renal angiomyolipoma, malignant PEComa, rhabdomyosarcoma, other sarcoma | "Histologically or cytologically confirmed cancer of one of the following types:" | |
| inclusion inclusion · stage extent · confidence 0.95 | Stage IV disease | "Stage IV disease" | |
| inclusion inclusion · performance status · confidence 0.98 | Adequate performance status (ECOG 0-2) | "Adequate performance status (ECOG 0-2)" | |
| inclusion inclusion · life expectancy · confidence 0.95 | Expected survival ≥ 3 months. | "Expected survival ≥ 3 months." | |
| inclusion inclusion · lesion burden · confidence 0.95 | Measurable disease by CT or MRI, Or lesions with skin infiltration. | "Measurable disease by CT or MRI, Or lesions with skin infiltration." | |
| inclusion inclusion · lab value · confidence 0.30 | Adequate hematology without ongoing transfusional support | "Adequate hematology without ongoing transfusional support" | |
| inclusion inclusion · lab value · confidence 0.97 | Hemoglobin > 9 g/dL | "hemoglobin \> 9 g/dL" | |
| inclusion inclusion · lab value · confidence 0.97 | Absolute neutrophil count (ANC) > 1,500 per mm^3 | "absolute neutrophil count (ANC) \> 1,500 per mm\^3" | |
| inclusion inclusion · lab value · confidence 0.97 | Platelets > 100,000 per mm^3 | "platelets \> 100,000 per mm\^3" | |
| inclusion inclusion · organ function · confidence 0.96 | Creatinine ≤ 2.0 x institutional upper limit of normal (IULN) | "creatinine ≤ 2.0 x institutional upper limit of normal (IULN)" | |
| inclusion inclusion · organ function · confidence 0.96 | Bilirubin ≤ 1.5 IULN | "bilirubin ≤ 1.5 IULN" | |
| inclusion inclusion · organ function · confidence 0.93 | AST ≤ 3.0 x IULN or 5 x IULN if known liver metastases | "aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases" | |
| inclusion inclusion · organ function · confidence 0.93 | ALT ≤ 3.0 x IULN or 5 x IULN if known liver metastases | "aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases" | |
| inclusion inclusion · lab value · confidence 0.95 | INR ≤1.5 | "International Normalized Ratio (INR) ≤1.5" | |
| inclusion inclusion · lab value · confidence 0.95 | PT ≤1.5×ULN | "PT≤1.5×ULN" | |
| inclusion inclusion · lab value · confidence 0.95 | aPTT≤1.5×ULN | "aPTT≤1.5×ULN" | |
| inclusion inclusion · pregnancy contraception · confidence 0.30 | Willing to use a medically approved contraceptive method from the enrollment to at least 120 days after the end of the study, and sperm donation or cryopreservation is not permitted during this period. | "Willing to use a medically approved contraceptive method from the enrollment to at least 120 days after the end of the study" | |
| inclusion inclusion · logistics · confidence 0.30 | Ability to comply with research visit schedules and other protocol requirements. | "Ability to comply with research visit schedules and other protocol requirements." | |
| exclusion exclusion · comorbidity · confidence 0.93 | Poor blood pressure control (systolic ≥150mmHg or diastolic ≥100mmHg) | "Poor blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg)" | |
| exclusion exclusion · comorbidity · confidence 0.92 | Poor control of diabetes (fasting blood sugar > 10 mmol/L) | "poor control of diabetes" | |
| exclusion exclusion · comorbidity · confidence 0.92 | ≥2 grade myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and ≥2 grade congestive heart failure (NYHA classification) | "≥2 grade myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and ≥2 grade congestive heart failure (NYHA classification)" | |
| exclusion exclusion · comorbidity · confidence 0.93 | Active or uncontrolled severe infections requiring systemic antibacterial, antifungal, or antiviral treatment (≥CTCAE grade 2), including tuberculosis; history of active tuberculosis | "active or uncontrolled severe infections requiring systemic antibacterial, antifungal, or antiviral treatment" | |
| exclusion exclusion · comorbidity · confidence 0.95 | Uncontrolled ascites, pleural effusion, or pericardial effusion that require repeated drainage | "Uncontrolled ascites, pleural effusion, or pericardial effusion that require repeated drainage" | |
| exclusion exclusion · comorbidity · confidence 0.90 | Active hepatitis (HBV/HCV viral load thresholds; eligible if on antiviral therapy below thresholds) | "With active hepatitis" | |
| exclusion exclusion · comorbidity · confidence 0.96 | History of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases | "History of immunodeficiency, including HIV positive or subjects with other acquired or congenital immunodeficiency diseases" | |
| exclusion exclusion · comorbidity · confidence 0.93 | Active autoimmune disease requiring systemic treatment within the past two years, with exceptions (non-systemic skin disease treatment, autoimmune thyroiditis-induced hypothyroidism on stable replacement) | "Active autoimmune disease requiring systemic treatment within the past two years" | |
| exclusion exclusion · comorbidity · confidence 0.93 | Severe hypersensitivity reactions after using monoclonal antibodies | "Subjects who have experienced severe hypersensitivity reactions after using monoclonal antibodies" | |
| exclusion exclusion · comorbidity · confidence 0.93 | Known allergy to the active ingredients or excipients of the study drug | "individuals who are known to be allergic to the active ingredients or excipients of the study drug" | |
| exclusion exclusion · washout · confidence 0.30 | Participated or currently participating in another clinical study within the past 4 weeks prior to study entry | "Have participated or are currently participating in another clinical study within the past 4 weeks prior to study entry" | |
| exclusion exclusion · washout · confidence 0.30 | Received a live vaccine within the past 30 days prior to the first dose or plan to receive a live vaccine during the study | "Received a live vaccine within the past 30 days prior to the first dose or plan to receive a live vaccine during the study" | |
| exclusion exclusion · comorbidity · confidence 0.95 | History of severe allergies | "History of severe allergies" | |
| exclusion exclusion · comorbidity · confidence 0.93 | At risk of bleeding, or with impaired coagulation function, or currently receiving thrombolytic therapy | "At risk of bleeding, or with impaired coagulation function, or currently receiving thrombolytic therapy" | |
| exclusion exclusion · comorbidity · confidence 0.95 | History of substance abuse with an inability to abstain or a history of mental illness | "History of substance abuse with an inability to abstain or a history of mental illness" | |
| exclusion exclusion · comorbidity · confidence 0.95 | History of a clearly defined neurological or psychiatric disorder, such as dementia, epilepsy, or seizure susceptibility | "Subjects who have a history of a clearly defined neurological or psychiatric disorder, such as dementia, epilepsy, or a history of seizure susceptibility" | |
| exclusion exclusion · comorbidity · confidence 0.30 | Serious underlying condition that in the investigator's opinion would endanger the subject's safety or impair ability to complete the study, or other reasons not to be enrolled | "have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study" | |
| exclusion exclusion · logistics · confidence 0.30 | Serious and/or unstable medical, psychological, or other condition, or any condition affecting the study protocol and follow-up plan, including psychological, familial, social, or geographic factors | "or who have any condition that would affect the study protocol and follow-up plan, including psychological, familial, social, or geographic factors" |
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: * Individuals able to understand and give written informed consent. * Histologically or cytologically confirmed cancer of one of the following types: PAGET's disease of scrotum with infiltrating sweat gland carcinoma Paraganglioma Pheochromocytom, Renal angiomyolipoma Malignant perivascular epithelioid cell tumor, Rhabdomyosarcom Other sarcoma rather than rhabdomyosarcom * Stage IV disease * Adequate performance status (ECOG 0-2) * Expected survival ≥ 3 months. * Measurable disease by CT or MRI, Or lesions with skin infiltration. * Adequate hematology without ongoing transfusional support (hemoglobin \> 9 g/dL, absolute neutrophil count (ANC) \> 1,500 per mm\^3, platelets \> 100,000 per mm\^3). * Adequate renal and hepatic function (creatinine ≤ 2.0 x institutional upper limit of normal (IULN), bilirubin ≤ 1.5 IULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases). * Adequate coagulation function: International Normalized Ratio (INR) ≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN. * Willing to use a medically approved contraceptive method from the enrollment to at least 120 days after the end of the study, and sperm donation to another person or cryopreservation for fertilization and reproduction is not permitted during this period. * Ability to comply with research visit schedules and other protocol requirements. Exclusion Criteria: * With any severe and/or uncontrolled disease. Including: (1)Poor blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); (2) poor control of diabetes (fasting blood sugar \[FBG\] \>10mmol/L); ≥2 grade myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and ≥2 grade congestive heart failure (NYHA classification); (3)active or uncontrolled severe infections requiring systemic antibacterial, antifungal, or antiviral treatment (≥CTCAE 2-level infection), including tuberculosis infection; A history of active tuberculosis; (4)Uncontrolled ascites, pleural effusion, or pericardial effusion that require repeated drainage; * With active hepatitis (transaminase levels not meeting inclusion criteria; HBV reference: HBV DNA≥2000 IU/ml or ≥10\^4 copies/ml; HCV reference: HCV RNA≥2000 IU/ml or ≥10\^4 copies/ml; after nucleoside analog antiviral therapy below the above standard, can be included; chronic hepatitis B virus carrier, HBV DNA\<10\^4 IU/ml, must be treated with antiviral drugs during the trial period to be eligible for enrollment); * History of immunodeficiency, including HIV positive or subjects with other acquired or congenital immunodeficiency diseases; * Active autoimmune disease requiring systemic treatment within the past two years, or subjects with an autoimmune disease that the investigator judges may recur or is planned for treatment; except: non-systemic treatment of skin diseases (e.g. vitiligo, alopecia, psoriasis or eczema); autoimmune thyroiditis-induced hypothyroidism requiring stable dose replacement therapy with hormones; 13. Subjects who have experienced severe hypersensitivity reactions after using monoclonal antibodies; individuals who are known to be allergic to the active ingredients or excipients of the study drug; * Have participated or are currently participating in another clinical study within the past 4 weeks prior to study entry; * Received a live vaccine within the past 30 days prior to the first dose or plan to receive a live vaccine during the study; * History of severe allergies; * At risk of bleeding, or with impaired coagulation function, or currently receiving thrombolytic therapy; * History of substance abuse with an inability to abstain or a history of mental illness; * Subjects who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study, or who, in the opinion of the investigator, have other reasons not to be enrolled; Subjects who have a history of a clearly defined neurological or psychiatric disorder, such as dementia, epilepsy, or a history of seizure susceptibility; * Subjects who, in the opinion of the investigator, have a serious underlying condition that would endanger the subject's safety or impair the subject's ability to complete the study (such as severe diabetes, thyroid disorders, and mental illness), or who have a serious and/or unstable medical, psychological, or other condition (including laboratory abnormalities) that would affect the subject's safety or the subject's ability to provide informed consent, or who have any condition that would affect the study protocol and follow-up plan, including psychological, familial, social, or geographic factors;
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- Fudan University Cancer Hospital, Shanghai