OncoMatch/Clinical Trials/NCT07679399
A Phase II Study of Adjuvant Durvalumab Combined With GEMOX/GC Chemotherapy Followed by Lenvatinib Versus Capecitabine in Biliary Tract Cancer.
Is NCT07679399 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies multiple treatments including Durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib and Capecitabine for biliary tract neoplasms immunotherapy.
Treatment: Durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib · Capecitabine — This study is designed as a prospective, randomized, open-label, phase II clinical trial to systematically evaluate the efficacy and safety of durvalumab combined with GEMOX/GC chemotherapy followed by lenvatinib, compared with capecitabine monotherapy, as adjuvant therapy for biliary tract cancer (BTC) after curative-intent resection.The primary objective is to determine whether the combination regimen can significantly improve the 1-year recurrence-free survival (RFS) rate. Secondary objectives include assessment of overall survival (OS) and the incidence of treatment-related adverse events. The overall aim is to identify a more effective and safer treatment strategy for postoperative adjuvant therapy in BTC.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: immunotherapy
Who has previously received immunotherapy or chemotherapy
Cannot have received: chemotherapy
Who has previously received immunotherapy or chemotherapy
Lab requirements
Blood counts
Hb ≥ 90 g/L; Neutrophils ≥ 1.5 × 10^9/L; PLT ≥100×10^9/L
Kidney function
creatinine ≤ 1.5 × ULN, or creatinine clearance rate (CCr) > 50 mL/min (Cockcroft-Gault)
Liver function
ALT and AST ≤ 2.5 × ULN; serum bilirubin ≤ 2.0 × ULN; albumin ≥ 2.8 g/dL; any clinically significant biliary obstruction should be relieved before enrollment
The hematology and organ functions are adequate. ... Hb ≥ 90 g/L; Neutrophils ≥ 1.5 × 10^9/L; PLT ≥100×10^9/L ... ALT and AST ≤ 2.5 × ULN; serum bilirubin ≤ 2.0 × ULN ... albumin ≥ 2.8 g/dL ... creatinine ≤ 1.5 × ULN, or creatinine clearance rate (CCr) > 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07679399 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages