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

NCT ID: NCT05532059

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2028-08-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GPLET

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

Group Type: EXPERIMENTAL

Lenvatinib, tislelizumab, gemcitabine and cisplatin

Intervention Type: DRUG

Lenvatinib, tislelizumab, gemcitabine and cisplatin

GP

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

Group Type: ACTIVE_COMPARATOR

gemcitabine and cisplatin

Intervention Type: DRUG

gemcitabine and cisplatin

Interventions

Lenvatinib, tislelizumab, gemcitabine and cisplatin

Lenvatinib, tislelizumab, gemcitabine and cisplatin

Intervention Type: DRUG

gemcitabine and cisplatin

gemcitabine and cisplatin

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

weilin wang, doctor

Role: primary

wam@zju.edu.cn

+86 0571 87783820

Other Identifiers

20220901

Identifier Type: -

Identifier Source: org_study_id