OncoMatch/Clinical Trials/NCT06607276
Phase 2 Trial of Adjuvant Adebrelimab Combined With Capecitabine in High-Risk Resected Cholangiocarcinoma: ACHIEVE
Is NCT06607276 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Adebrelimab and capecitabine and capecitabine for cholangiocarcinoma cancer.
Treatment: Adebrelimab and capecitabine · capecitabine — Biliary tract malignancies (BTC) are malignant tumors that originate from the epithelium of the bile ducts. Currently, the optimal treatment for biliary tract malignancies is radical surgical resection. In recent years, with the advancement of imaging technology and surgical techniques, there has been certain progress in the diagnosis and treatment of biliary tract malignancies. However, the surgical resection rate and long-term survival rate after surgery are still not satisfactory, and the high postoperative recurrence rate is an important factor affecting the long-term survival of patients. Therefore, there is an urgent need to explore new postoperative adjuvant treatment plans to reduce postoperative tumor recurrence, which is of great significance for extending the survival of patients with biliary tract malignancies. In the NCCN and CSCO guidelines, capecitabine is listed as a category I recommendation for adjuvant treatment of biliary tract malignancies (BTC). However, in clinical practice, the use of capecitabine or tegafur for postoperative patients with cholangiocarcinoma at high risk of recurrence still has a high recurrence rate. Therefore, there is still a huge unmet need in the clinical adjuvant treatment after surgery for biliary tract malignancies. Based on the above background, we plan to carry out a randomized, open, and comparative study to observe the efficacy and safety of Adebrelimab combined with capecitabine for adjuvant treatment in patients with biliary tract malignancies after surgery, and to explore treatment methods to improve the efficacy of postoperative adjuvant treatment for cholangiocarcinoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-cancer therapy
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5×10^9/L; Platelets ≥75×10^9/L; Hemoglobin ≥90 g/L
Kidney function
Serum creatinine ≤1.5×ULN; or Cr clearance rate >50 mL/min
Liver function
Serum albumin ≥30g/L; Serum total bilirubin ≤1.5×ULN; ALT and AST ≤3×ULN
Laboratory test values within 7 days prior to the first dose of study medication meet the following criteria: ... Complete blood count: ... Absolute neutrophil count ≥1.5×10^9/L; Platelets ≥75×10^9/L; Hemoglobin ≥90 g/L; ... Serum albumin ≥30g/L; Serum total bilirubin ≤1.5×ULN; ALT and AST ≤3×ULN; Serum creatinine ≤1.5×ULN; or Cr clearance rate >50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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