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A Phase II Study of Adjuvant Durvalumab Combined With GEMOX/GC Chemotherapy Followed by Lenvatinib Versus Capecitabine in Biliary Tract Cancer.

NCT07679399 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2026-07-01

No results posted yet for this study

Summary

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.

Conditions

  • Biliary Tract Neoplasms Immunotherapy

Interventions

COMBINATION_PRODUCT

Durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib

Regimen of durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib

DRUG

Capecitabine

Capecitabine monotherapy regimen

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-01-01
Completion
2027-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07679399 on ClinicalTrials.gov