OncoMatch/Clinical Trials/NCT07135544
A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer
Is NCT07135544 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Adebrelimab combined with the GC regimen and Apatinib for biliary tract cancer.
Treatment: Adebrelimab combined with the GC regimen and Apatinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Disease stage
Required: Stage TXNX, TXNXM1 (UICC/AJCC TNM staging system (9th edition, 2024))
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery — radical resection
have undergone radical resection surgery for biliary cancer, and whose disease recurs 2 years after the surgery can be included
Cannot have received: immune checkpoint inhibitor
Patients who received immune checkpoint inhibitors before enrollment, or those who directly received another stimulatory or co-inhibitory T-cell receptor (such as CTLA-4, CD137)
Cannot have received: investigational drug
Patients who used any other investigational drug within 4 weeks before enrollment
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 75 × 10^9/L; Hemoglobin ≥ 90 g/L
Kidney function
Creatinine ≤ 1.5 x ULN
Liver function
Serum total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN; Albumin ≥ 3 g/dL
The patient's organ and hematological system functions meet the following requirements: Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count ≥ 75 × 10^9/L; Hemoglobin ≥ 90 g/L; Serum total bilirubin ≤ 1.5 x ULN; Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 2.5 x ULN; Albumin ≥ 3 g/dL; Creatinine ≤ 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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