Actively Recruiting
Exploring the Efficacy and Safety of Tislelizumab in Combination With S-1 in the Treatment of Patients With Postoperative Recurrent High-risk Intrahepatic Cholangiocarcinoma
Led by Anhui Provincial Hospital · Updated on 2025-01-10
60
Participants Needed
2
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluating the efficacy and safety of treatment with Tislelizumab in combination with S-1 in patients with high-risk recurrent intrahepatic cholangiocarcinoma after radical surgery
CONDITIONS
Official Title
Exploring the Efficacy and Safety of Tislelizumab in Combination With S-1 in the Treatment of Patients With Postoperative Recurrent High-risk Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, both male and female
- Pathologically confirmed intrahepatic cholangiocarcinoma after R0 or R1 resection with high-risk factors (positive margins, multiple tumor nodes, positive lymph nodes, positive perineural infiltration, tumor >5 cm, or combined vascular invasion)
- Enhanced CT scans of chest, abdomen, and pelvis within 30 days before surgery showing no distant metastases
- No chemotherapy, radiotherapy, immunotherapy, or interventional therapy within 3 months before surgery
- Child-Pugh grade A or B and ECOG performance status of 0-1
- Normal organ function before treatment, including specified blood counts and liver and kidney test limits
- Normal coagulation function within specified limits
- For hepatitis B or C infections, viral loads within defined safe limits and willingness to receive antiviral therapy during the study
- No major heart, lung, or kidney abnormalities
- No history of gastrointestinal bleeding
- Signed informed consent form
You will not qualify if you...
- Incomplete tumor resection or pathological diagnosis other than intrahepatic cholangiocarcinoma
- Pregnant or breastfeeding women
- Presence of other malignant tumors
- Active or history of autoimmune diseases
- Uncontrolled significant cardiac diseases such as congestive heart failure above NYHA II, unstable angina, recent myocardial infarction, or serious arrhythmias
- Congenital or acquired immunodeficiency
- Uncontrolled infections above grade 2
- Psychiatric disorders
- Participation in other clinical trials within the past 3 months
- Postoperative use of other targeted therapies, immunotherapy, or systemic chemotherapy
- Any condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
No.2 People's Hospital of Fuyang city
Fuyang, Anhui, China, 236015
Actively Recruiting
2
Anhui province hospital
Hefei, Anhui, China, 230000
Actively Recruiting
Research Team
J
Ji-Zhou Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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