Adebrelimab Plus S-1 for Resected Cholangiocarcinoma

Sponsor
Xingjun Guo
Study ID
NCT07561775
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Biliary Tract Cancer
  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab — DRUG
    Adebrelimab will be administered intravenously at a dose of 1200 mg on Day 1 of each 3-week cycle for a total of 4 cycles as adjuvant therapy after curative resection.
  • S-1 — DRUG
    S-1 will be administered orally at a dose of 40 mg/m² twice daily on Days 1-28 of each 6-week cycle, followed by a 2-week rest period, for a total of 4 cycles.

Study Details

The goal of this clinical trial is to learn whether adebrelimab combined with S-1 works as an adjuvant treatment for patients with cholangiocarcinoma after curative surgery. It will also learn about the safety of this treatment. The main questions it aims to answer are: * Does adebrelimab combined with S-1 reduce the risk of cancer recurrence after surgery? * What side effects do participants experience when receiving this treatment? All participants in this study will receive adebrelimab combined with S-1. There is no comparison group in this study. Participants will: * Receive adebrelimab by intravenous infusion once every 3 weeks for 4 cycles * Take S-1 by mouth twice daily for 4 weeks, followed by a 2-week rest, for 4 cycles * Visit the hospital regularly for checkups, laboratory tests, and imaging examinations (CT or MRI) * Be followed up for safety and survival after completing treatment

Key Dates

First listed
May 1, 2026
Start date
Apr 21, 2026
Status verified
Apr 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2032

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adebrelimab plus S-1
    Participants will receive adebrelimab in combination with S-1 as adjuvant therapy after curative resection. Adebrelimab will be administered intravenously at 1200 mg every 3 weeks for 4 cycles. S-1 will be administered orally at 40 mg/m² twice daily on Days 1-28 of a 6-week cycle, followed by a 2-week rest, for 4 cycles.

Primary Outcome Measure

1-year Relapse-Free Survival (RFS) rate [ Time Frame: 1 year after surgery ]

Central Contacts

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