Actively Recruiting
Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-10
100
Participants Needed
1
Research Sites
343 weeks
Total Duration
On this page
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,we aim 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 Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients
- World Health Organization (WHO)/ECOG physical status (PS) of 0 or 1
- At least 1 target lesion measurable by RECIST 1.1 criteria
- No previous immunotherapy, including CTLA 4, PD-L1, or PD-1 inhibitors
- Adequate organ and bone marrow function defined as hemoglobin ≥ 9.0 g/dL, neutrophil count ≥ 1.5 x 10^9/L, and platelet count ≥ 100 x 10^9/L
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
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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