Adebrelimab Plus S-1 for Resected Cholangiocarcinoma

Starting soon · Phase 2

Conditions studied: Cholangiocarcinoma, Biliary Tract Cancer

In brief

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 facts

Study ID

NCT07561775

Run by

Xingjun Guo

People needed

40

Starts

2026-04-21

Expected to finish

2032-01-01

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Full record on ClinicalTrials.gov

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