Adebrelimab Plus S-1 for Resected Cholangiocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXingjun Guo
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Adebrelimab
DrugAdebrelimab 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
DrugS-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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Adebrelimab plus S-1Experimental treatment 2 interventions
Trial outcomes
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.
Time frame
1 year after surgerySecondary outcomes
1
Relapse-Free Survival (RFS)
Time from surgery to the first documented disease recurrence or death from any cause.
Time frame
Up to 5 years after surgery2
Overall Survival (OS)
Time from first treatment to death from any cause.
Time frame
Up to 5 years3
Incidence of adverse events
Number and severity of adverse events assessed according to NCI CTCAE version 5.0.
Time frame
Up to 90 days after last doseLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xingjun Guo
Lead sponsor
Tongji Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: