Iparomlimab and Tuvonralimab Combined With GC in Advanced ICC (NCT07152769) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Iparomlimab and Tuvonralimab Combined With GC in Advanced ICC
China104 participantsStarted 2025-10-15
Plain-language summary
This study is a randomized, controlled, open-label, single center clinical study. This study is designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Combined With GC versus Sintilimab Combined With GC as first-line therapy in advanced ICC.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Signed written informed consent obtained prior to any trial-related procedures.
* Male or female, ≥18 years and ≤75 years.
* Histologically confirmed unresectable advanced or metastatic intrahepatic cholangiocarcinoma (ICC). Patients who developed recurrence more than 6 months after radical surgery are eligible. If adjuvant therapy (chemotherapy and/or radiotherapy) was received, recurrence must have occurred more than 6 months after completion of adjuvant therapy.
* At least one measurable tumor lesion according to RECIST version 1.1 criteria.
* No prior systemic therapy (chemotherapy, targeted therapy, or immunotherapy) for advanced/metastatic disease.
* Life expectancy of at least 12 weeks.
* ECOG Performance Status (PS) of 0 or 1.
* Subjects must meet the following laboratory parameters: 1)Absolute Neutrophil Count (ANC): ≥ 1.5 × 10⁹/L (without granulocyte colony-stimulating factor support within the last 14 days). 2)Platelets: ≥ 100 × 10⁹/L (without transfusion within the last 14 days). 3)Hemoglobin: \> 9 g/dL (without transfusion or erythropoietin use within the last 14 days). 4)Total Bilirubin: ≤ 1.5 × Upper Limit of Normal (ULN). 5)Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT): ≤ 2.5 × ULN. 6)Creatinine Clearance: Calculated creatinine clearance (using the Cockcroft-Gault formula) ≥ 60 mL/min.
* The subject is willing and able to comply with the protocol during the study period, including receiving treatment, adhering to contr…