Cadonilimab Combined With Gem/Cis as First Line Therapy in Patients With Advanced ICC
Intrahepatic Cholangiocarcinoma
About this trial
This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma focused on measuring cadonilimab (anti-PD-1/CTLA-4 bispecific antibody)
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically diagnosed intrahepatic cholangiocarcinoma (ICC) At least 1 measurable lesion (according to RECIST1.1) Have not previously received any systemic treatment Age 18-75 years old, both male and female ECOG performance status score (PS score) 0-2 point Adequate medullary hematopoiesis function: Neutrophils≥1.5*10^9/L; platelets≥100*10^9/L Adequate renal function: creatinine clearance > 60ml/min Adequate hepatic function: Bilirubin ≤ 1.5 times the upper limit of normal No cardiac insufficiency or chest pain (medically uncontrollable); no myocardial infarction in the 12 months prior to study initiation Expectation survival time over 3 months The patient must sign an informed consent form Exclusion Criteria: History of another primary malignancy Brain metastases or spinal cord compression Uncontrolled intercurrent illness Have active or previously recorded autoimmune or inflammatory diseases (eg Rheumatoid arthritis, psoriasis, systemic lupus erythematosus, AIDS, etc) Have received allogeneic organ transplantation Control of concurrent complications, including but not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, poorly controlled arrhythmia, active interstitial lung disease ( ILD), severe chronic gastrointestinal disorders associated with diarrhea symptoms, may limit compliance with the psychiatric/social conditions required by the trial, and substantially increase the risk of adverse events or affect the ability of patients to sign written consent forms History of active primary immunodeficiency Pregnant or lactating women Severe or uncontrolled infections Patients with history of severe neurological or psychiatric illness, including dementia or epilepsy; Patients with drug abuse, medical, psychological or social conditions that may interfere with the study results or the assessment of the study results; Patients are unsuitable for the enrollment according to investigator's judgement.
Sites / Locations
- Eastern hepatobilliary surgery hospital
Arms of the Study
Arm 1
Experimental
Cadonilimab+Gem/Cis