Actively Recruiting
Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-10
80
Participants Needed
1
Research Sites
226 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
Cholangiocarcinoma (CCA) is a heterogeneous group of cancers arising from the epithelial cells of bile ducts. Because of highly aggressive malignancy, most of the patients are diagnosed at an advanced stage and lose the chance to undergo surgery. As more effective and novel chemotherapy, targeted therapies, and immunotherapy become available, multiple treatments can be chosen for the patients with advanced CCA. Cytotoxic cell death during tumor chemotherapy triggers antigen release and induces strong anti-tumor effects of T cells. Tyrosine kinase inhibitors (TKI) can reduce the expression of PD-L1 and inhibit Treg cell infiltration, and together with immune checkpoint inhibitors, they can relieve tumor immunosuppressive microenvironment. Therefore, the study aims to investigate the safety and efficacy of Lenvatinib, Tislelizumab combined with Gemcitabine plus Cisplatin (GPLET) in the treatment of advanced cholangiocarcinoma.
CONDITIONS
Official 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.
- World Health Organization (WHO) / ECOG physical status (PS) 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 normal limit; AST ≤ 2.5 times upper normal limit.
- Voluntary participation and signed informed consent.
You will not qualify if you...
- Active or previously documented autoimmune or inflammatory disease.
- Uncontrolled complications.
- History of other primary cancers.
- Active infection.
- Women who are pregnant or breastfeeding.
- Severe allergic history or specific constitution.
- Investigator deems participation inappropriate.
AI-Screening
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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
CONTACT
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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