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OncoMatch/Clinical Trials/NCT06320301

Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC)

Is NCT06320301 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Adebrelimab + GEMOX + TKI for biliary tract cancer.

Phase 2RecruitingSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNCT06320301Data as of May 2026

Treatment: Adebrelimab + GEMOX + TKIPatients 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).

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Extracted eligibility criteria

Cancer type

Cholangiocarcinoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy

Lab requirements

Blood counts

Hemoglobin ≥ 90 G/L; Neutrophil count ≥ 1.5 × 10^9/L; Platelet count ≥ 50 × 10^9/L

Kidney function

Creatinine ≤ 1.5x ULN or Cr clearance > 50 mL/min

Liver function

ALT and AST ≤ 2.5x ULN; total bilirubin ≤ 1.5x ULN

Cardiac function

LVEF ≥ 60%

The functions of main organs are basically normal...see protocol for details

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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