Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma

NCT05823311 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Phase

Phase 3

Started

2023-09-01

Last updated

2025-02-10

Condition(s) studied

Advanced Cholangiocarcinoma

Investigational drug(s) / intervention(s)

Lenvatinib, tislelizumab, gemcitabine and cisplatinGemcitabine and cisplatin →

Lenvatinib, tislelizumab, gemcitabine and cisplatin: Intravenous injection: gemcitabine and cisplatin (CG) + tislelizumab； Oral administration: lenvatinib.

Gemcitabine and cisplatin: Intravenous injection: gemcitabine and cisplatin (CG) + placebo； Oral administration: placebo.

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, the study aims 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

75 Years

Healthy volunteers

Inclusion Criteria: * Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients. * Expected survival period \> 12 weeks. * The World Health Organization (WHO) / ECOG physical status (PS) was 0 or 1. * There was at least one target lesion that matched the RECIST 1.1 criteria at baseline. * 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: Hemoglobin (Hb)≥9.0g/dL; Neutrophils (ANC) ≥ 1.5\* 10\^9/L; Platelet (Pt) ≥ 50\*10\^9/L; ALT≤2.5×ULN（Normal upper limit); AST≤2.5×ULN. * Voluntary participation and signing of informed consent. 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. * Patients with severe allergic history or specific constitution. * Researchers consider it inappropriate to participate in the test.

Primary outcome measure(s)

Objective remission rate (ORR) — At the end of 4 treatment cycles(each cycle is 21 days)
The proportion of patients with at least one complete response (CR) or partial response (PR) (%)

Trial sites (1)

Facility	City	Region	Status
The Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	Recruiting

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

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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 NCT05823311 on ClinicalTrials.gov ↗ ← All trials in China