Actively Recruiting
A Randomized, Double-blind, Multicenter Study of Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin for Advanced Cholangiocarcinoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-10
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
T
The First Affiliated Hospital of Zhengzhou University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Advanced cholangiocarcinoma (CCA) is a group of aggressive cancers that start in the bile duct cells and are often diagnosed late, making surgery impossible for many patients. With new chemotherapy, targeted therapies, and immunotherapy options emerging, this research evaluates the safety and effectiveness of combining Lenvatinib, Tislelizumab, and Gemcitabine plus Cisplatin (GPLET) for treating advanced CCA. The study is a Phase 3 randomized, double-blind trial sponsored by the Second Affiliated Hospital, School of Medicine, Zhejiang University. Participants are assigned to one of two groups. One group receives intravenous gemcitabine and cisplatin plus tislelizumab and oral lenvatinib, while the other group gets intravenous gemcitabine and cisplatin with placebo and oral placebo tablets. Treatments are given in 21-day cycles, with four cycles making up the primary treatment period. This design allows comparison between the combined therapy and standard chemotherapy with placebo. During the study, participants will be monitored for tumor response, with the main outcome being the objective remission rate after four treatment cycles. Additional measures include progression-free survival and overall survival over up to 60 months. Safety and organ function will be checked regularly, and participants will be followed long term to assess treatment impact and side effects. Total participation duration varies with follow-up assessments continuing after treatment completion.
CONDITIONS
Brief Title
Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients
- Expected survival period greater than 12 weeks
- WHO/ECOG physical status of 0 or 1
- At least one target lesion meeting RECIST 1.1 criteria at baseline
- No prior immunotherapy including CTLA-4, PD-L1, or PD-1 inhibitors
- Adequate organ and bone marrow function: Hemoglobin ≥9.0 g/dL; Neutrophils ≥1.5×10^9/L; Platelets ≥50×10^9/L; ALT ≤2.5 times upper limit of normal; AST ≤2.5 times upper limit of normal
- Voluntary participation with signed informed consent
You will not qualify if you...
- Active or previously documented autoimmune or inflammatory disease
- Uncontrolled medical complications
- History of other primary cancers
- Active infections
- Women who are pregnant or breastfeeding
- Severe allergic history or specific allergic constitution
- Any condition the researchers consider unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 treatment cycles, each lasting 21 days
Participants receive intravenous gemcitabine and cisplatin with either tislelizumab plus oral lenvatinib or placebo treatment.
Repeated visits for intravenous infusions and oral medication during each 21-day cycle
Duration - Up to 60 months from randomization
Participants are monitored for progression-free and overall survival following treatment completion.
Regular visits as determined by the study protocol for monitoring
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
W
Weilin Wang, doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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