A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Sys
This is an exploratory and prospective study, with the research subjects being patients with initially untreated and unresectable biliary tract tumors. The efficacy and safety of the treatment regimen consisting of Adebrelimab monoclonal antibody combined with targeted therapy and systemic chemotherapy were investigate
| Condition(s) | Biliary Tract Cancer, Biliary Tract Cancer (CCA) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is an exploratory and prospective study, with the research subjects being patients with initially untreated and unresectable biliary tract tumors. The efficacy and safety of the treatment regimen consisting of Adebrelimab monoclonal antibody combined with targeted therapy and systemic chemotherapy were investigated. |
| Who can participate | Inclusion Criteria: \- 1. Pathological or histological diagnosis of malignant tumor of the biliary tract; 2. Patients who are classified as TxNx and TxNxM1 according to the UICC/AJCC TNM staging system (9th edition, 2024), and who, based on the judgment of the research team, meet the criteria for newly diagnosed incurable cases or are not suitable for surgery; 3. Age: 18-80 years old; 4. Expected survival period \> 3 months; 5. Both genders are eligible; 6. ECOG PS score of 0 or 1; 7. No severe complications, such as hypertension, coronary heart disease, and history of mental illness, no severe allergy history; non-pregnant and non-lactating; 8. The patient's organ and hematological system functions meet the following requirements: 1. Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; 2. Pla |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Yongjun Chen |
| Locations | Wuhan, Hubei, China |
| Start date | 2025-08-14 |
| NCT ID | NCT07135544 |
| Official listing | https://clinicaltrials.gov/study/NCT07135544 |