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NCT Number: NCT05823311

Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of 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, the study aims 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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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.
  • 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.

Treatment and study plan

Lenvatinib, tislelizumab, gemcitabine and cisplatin

Drug

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

Gemcitabine and Cisplatin

Drug

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

Primary outcomes

  1. Objective remission rate (ORR)

    Time frame: 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) (%)

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

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Weilin Wang, doctor

CONTACT

[email protected]

+86 0571 87783820

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • The Affiliated Tumor Hospital of Xinjiang Medical University
  • The First Affiliated Hospital of Zhengzhou University

Registry information

Official study title

A Randomized, Double-blind, Multicenter Study of Lenvatinib, Temalizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 21, 2023
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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