Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC)
Trial Parameters
Brief Summary
Patients with advanced biliary tract malignant tumors who had not received systematic treatment before and could not be cured were selected as the subjects of the study. The primary endpoint of the study was investigator-assessed 6-month progression-free survival (6-month PFS%) based on the RECIST v1.1 criteria, and 43 subjects were planned to be enrolled. Patients eligible for enrollment will receive Adebrelimab and a tyrosine kinase inhibitor (TKI) in combination with gemcitabine and oxaliplatin (GEMOX).
Eligibility Criteria
Inclusion Criteria: * 1\) The patient voluntarily participated in the study and signed the informed consent; * 2\) ≥ 18 years old (calculated on the day of signing the informed consent), male or female; * 3\) Patients with advanced biliary tract malignant tumors confirmed by histopathology or cytology; * 4\) Subjects must be able to provide fresh or archived tumor tissue (formalin-fixed, paraffin-embedded \[FFPE\] blocks or at least 5 unstained FFPE slides) and their pathology reports. If less than 5 unstained slides are available from the subject or tumor tissue is not available (e.g., because of exhaustion of previous diagnostic tests), enrollment may be allowed on a case-by-case basis after discussion; * 5\) The subject is not suitable for surgery, or has progressed after surgery and/or local treatment; * 6\) Patients with progression after local therapy, where local therapy (including but not limited to surgery, radiotherapy, arterial embolization, arterial infusion, radiofrequency