Adebrelimab Plus S-1 for Resected Cholangiocarcinoma

NCT07561775 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2026-S001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cholangiocarcinoma; Biliary Tract Cancer

Keywords

Adebrelimab; S-1; Adjuvant Therapy; Postoperative Treatment; PD-L1 Inhibitor; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 1-year Relapse-Free Survival (RFS) rate

  The proportion of participants who remain alive without disease recurrence at 1 year after surgery.

  1 year after surgery

Secondary Outcomes (3)

• Relapse-Free Survival (RFS)

  Up to 5 years after surgery

• Overall Survival (OS)

  Up to 5 years

• Incidence of adverse events

  Up to 90 days after last dose

Study Arms (1)

Adebrelimab plus S-1

EXPERIMENTAL

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.

Drug: Adebrelimab; Drug: S-1

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.

Adebrelimab plus S-1

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.

Adebrelimab plus S-1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or pathologically confirmed malignant cholangiocarcinoma.
• Patients who have undergone curative surgical resection.
• Age between 18 and 75 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Expected survival time \>3 months.
• Adequate organ and bone marrow function, including:Absolute neutrophil count ≥1.5 × 10\^9/L,Platelet count ≥75 × 10\^9/L,Hemoglobin ≥90 g/L,Total bilirubin ≤1.5 × upper limit of normal (ULN),AST and ALT ≤2.5 × ULN,Albumin ≥3 g/dL,Serum creatinine ≤1.5 × ULN.
• Ability to understand and willingness to sign written informed consent.
• For patients of childbearing potential, willingness to use effective contraception during the study and for at least 1 month after the last dose; negative pregnancy test within 72 hours prior to enrollment.

You may not qualify if:

• Prior treatment with immune checkpoint inhibitors or other agents targeting T-cell co-stimulatory or co-inhibitory pathways (e.g., CTLA-4, CD137).
• Use of any investigational drug within 4 weeks prior to enrollment.
• Active autoimmune disease or history of autoimmune disease (e.g., interstitial lung disease, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, or hypothyroidism requiring hormone replacement).
• Known immunodeficiency, including HIV infection, active hepatitis B (HBV DNA \>500 IU/mL), active hepatitis C (HCV RNA above detection limit), or co-infection of HBV and HCV.
• Severe infection within 4 weeks prior to first dose or unexplained fever \>38.5°C during screening.
• History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Uncontrolled psychiatric disorders.
• Severe or uncontrolled comorbidities that may interfere with study participation (e.g., unstable angina, myocardial infarction within 6 months, symptomatic arrhythmia, congestive heart failure, uncontrolled diabetes, or uncontrolled infection).
• History of other malignancies within the past 5 years, except for non-melanoma skin cancer or carcinoma in situ.
• Known hypersensitivity to study drugs or monoclonal antibodies.
• Inability or unwillingness to provide informed consent.

Sponsors & Collaborators

• Xingjun Guo: lead

MeSH Terms

Conditions

Cholangiocarcinoma; Biliary Tract Neoplasms

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Xingjun Guo

CONTACT

027-83665315; xjguo@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 1, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2032
• Last Updated: May 1, 2026

Record last verified: 2026-04