Biliary tract tumor
Conditions
Interventions
treatment group:Adebrelimab+anti-angiogenic + GC
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years, both male and female are eligible; 2. Biopsy- or pathologically-confirmed unresectable, locally advanced, or metastatic biliary tract tumors (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer); 3. No prior systemic anti-tumor treatment; 4. At least one measurable lesion (measurable according to RECIST 1.1); 5. ECOG performance status: 0–1; 6. Expected survival >= 12 weeks; 7. Baseline hematology and biochemistry must meet the following criteria: - White blood cell count >= 3.0 × 10^9/L - Hemoglobin >= 90 g/L - Absolute neutrophil count >= 1.5 × 10^9/L - Platelet count >= 100 × 10^9/L - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 30 g/L 8. Women of childbearing potential must agree to use contraception during the study and for 6 months after the study (e.g., intrauterine device, contraceptive pills, or condoms); must have a negative serum or urine pregnancy test within 7 days prior to enrollment, and must not be breastfeeding; men must agree to use contraception during the study and for 6 months after the study; 9. Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Histologically confirmed diagnosis of neuroendocrine carcinoma; 2. Allergy to adebrelimab, anti-angiogenic drugs, gemcitabine, cisplatin, or their excipients; 3. Previous systemic treatment; 4. Presence of symptomatic pleural effusion, pericardial effusion, or ascites that the investigator deems requires frequent drainage; 5. History of organ transplantation (including autologous bone marrow and peripheral stem cell transplants); 6. Active or uncontrolled severe infection (>=CTCAE 5.0 grade 2), including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia, or unexplained fever >38.5? before the first dose; 7. History of psychiatric drug abuse that cannot be stopped, or presence of psychiatric disorders; 8. Previous or concurrent malignancies within 5 years that require active treatment (except for adequately treated cases with an expected 5-year survival rate >90%, such as basal cell carcinoma, squamous cell skin cancer, cervical carcinoma in situ, or breast carcinoma in situ); 9. Uncorrectable coagulation disorders; 10. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass surgery within 6 months prior to enrollment; congestive heart failure NYHA class >=2; ventricular arrhythmias requiring medication (including QTc interval >=450 ms for men, >=470 ms for women); left ventricular ejection fraction (LVEF) 10 mg/day prednisone or equivalent, continued within 2 weeks prior to enrollment); 15. Occurrence of arterial or venous thromboembolic events within 6 months prior to the first dose, such as cerebrovascular events (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, or pulmonary embolism; 16. Digestive tract diseases or conditions that may affect drug absorption as judged by the investigator, including but not limited to active gastric or duodenal ulcers, ulcerative colitis, unresected gastrointestinal tumors with active bleeding, or other conditions deemed by the investigator to potentially cause gastrointestinal bleeding or perforation, or multiple factors affecting oral drug intake (e.g., difficulty swallowing, post-gastrointestinal surgery, chronic diarrhea, and intestinal obstruction). 17. Hypertension that is not adequately controlled by medication, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg; 18. Underwent surgery (excluding biopsy) within 28 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactZhou Jinxue
Henan Cancer Hospital
Outcome results
None listed