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

NCT05532059 | Recruiting Phase 2

• 1 other identifier: 20220901
• Study Type: interventional
• Target: 100
• 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,we aim 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; Gemcitabine and Cisplatin; Tislelizumab; Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• objective remission rate (ORR)

  According to RECIST v1.1, the proportion of patients with at least one complete response (CR) or partial response (PR) (%)

  4 cycle treatment (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

EXPERIMENTAL

intravenous gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 on days 1 and 8; oral lenvatinib 8 mg/day (\<60kg) or 12 mg/ d（≥60kg）from days 1 to 21; intravenous tislelizumab 200 mg on day 15

Drug: Lenvatinib, tislelizumab, gemcitabine and cisplatin

GP

ACTIVE COMPARATOR

intravenous gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 on days 1 and 8

Drug: gemcitabine and cisplatin

Interventions

Lenvatinib, tislelizumab, gemcitabine and cisplatin DRUG

Lenvatinib, tislelizumab, gemcitabine and cisplatin

GPLET

gemcitabine and cisplatin DRUG

gemcitabine and cisplatin

GP

Eligibility Criteria

• Age: 18 Years - 85 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.
• 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.

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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

lenvatinib; tislelizumab; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: September 8, 2022
• Study Start: January 31, 2022
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2028
• Last Updated: February 10, 2025

Record last verified: 2025-01

Locations

CN (1)