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NCT Number: NCT05532059

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

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.

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Key information

Conditions

Advanced Cholangiocarcinoma Adenocarcinoma Carcinoma Cholangiocarcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

weilin wang, doctor

CONTACT

[email protected]

+86 0571 87783820

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lenvatinib, tislelizumab, gemcitabine and cisplatin

Drug

Lenvatinib, tislelizumab, gemcitabine and cisplatin

Gemcitabine and Cisplatin

Drug

gemcitabine and cisplatin

Primary outcomes

  1. objective remission rate (ORR)

    Time frame: 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) (%)

Secondary outcomes

  1. progression-free survival (PFS)

    Time frame: From date of randomization until the date of first documented progression, assessed up to 60 months

    The time between the date of randomization and the date of radiographic progression as defined by RECIST1.1

  2. Overall survival time (OS)

    Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months

    The time between the date of randomization and death from any cause

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

A Phase Ⅱ, Open Label, Single-center Study of Lenvatinib and Tirelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma

Important dates

Study start
2022
Primary completion
2025
Study completion
2028
First posted
Sep 8, 2022
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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