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Clinical Trials in China / NCT05532059
Recruiting Phase 2

Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma

NCT05532059 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Phase 2
Started
2022-01-31
Last updated
2025-02-10

Condition(s) studied

Advanced Cholangiocarcinoma

Investigational drug(s) / intervention(s)

Lenvatinib, tislelizumab, gemcitabine and cisplatin →gemcitabine and cisplatin →

Lenvatinib, tislelizumab, gemcitabine and cisplatin: Lenvatinib, tislelizumab, gemcitabine and cisplatin

gemcitabine and cisplatin: gemcitabine and cisplatin

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients. * the world health organization (WHO)/ECOG physical state (PS) to 0 or 1. * at least 1 RECIST 1.1 standard target lesions. * not previously received immunotherapy, including but not limited to CTLA 4, PD-L1 or/and PD-1 inhibitors. * adequate organ and bone marrow function, defined as follows: 9.0 g/dL or higher hemoglobin; neutrophil count 1.5 x 109 / L; platelet count 100 x 109 / L. Exclusion Criteria: * Active or previously documented autoimmune disease or inflammatory disease. * Uncontrolled complications. * History of other primary malignancies. * Active infection. * Women who are pregnant or breastfeeding.

Primary outcome measure(s)

  • objective remission rate (ORR) — 4 cycle treatment (each cycle is 21 days)
    According to RECIST v1.1, the proportion of patients with at least one complete response (CR) or partial response (PR) (%)

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting

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Other trials for the same condition

Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement Recruiting
Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma Recruiting
Efficacy and Safety of TT-00420 (Tinengotinib) Tablets Versus Chemotherapy in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05532059 on ClinicalTrials.gov ↗ ← All trials in China