Clinical trial · Interventional
Adebrelimab Plus S-1 for Resected Cholangiocarcinoma
A Single-Arm, Exploratory Clinical Study of Adebrelimab Combined With S-1 in Patients With Resected Cholangiocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adebrelimab | Drug | Adebrelimab | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adebrelimab plus S-1
- description
- 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.
- interventionNames
- Drug: Adebrelimab
- Drug: S-1
Primary outcomes (1)
- measure
- 1-year Relapse-Free Survival (RFS) rate
- timeFrame
- 1 year after surgery
- description
- The proportion of participants who remain alive without disease recurrence at 1 year after surgery.
Secondary outcomes (3)
- measure
- Relapse-Free Survival (RFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available