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

NCT05823311 | Recruiting Phase 3

• 1 other identifier: 2023-0175
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Cholangiocarcinoma

Keywords

Lenvatinib; Tislelizumab; Gemcitabine and Cisplatin

Outcome Measures

Primary Outcomes (1)

• Objective remission rate (ORR)

  The proportion of patients with at least one complete response (CR) or partial response (PR) (%)

  At the end of 4 treatment cycles(each cycle is 21 days)

Secondary Outcomes (2)

• Progression-free survival (PFS)

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

• Overall survival time (OS)

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

Study Arms (2)

GPLET (Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin)

EXPERIMENTAL

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

Drug: Lenvatinib, tislelizumab, gemcitabine and cisplatin

CG (Gemcitabine and Cisplatin)

PLACEBO COMPARATOR

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

Drug: Gemcitabine and cisplatin

Interventions

Lenvatinib, tislelizumab, gemcitabine and cisplatin DRUG

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

GPLET (Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin)

Gemcitabine and cisplatin DRUG

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

CG (Gemcitabine and Cisplatin)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• The Affiliated Tumor Hospital of Xinjiang Medical University: collaborator

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Interventions

lenvatinib; tislelizumab; Gemcitabine; Cisplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Weilin Wang, doctor

CONTACT

+86 0571 87783820; wam@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: April 21, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 10, 2025

Record last verified: 2025-01

Locations

CN (1)