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

Zhejiang University

Status and phase: Enrolling; Phase 2

Conditions: Advanced Cholangiocarcinoma

Treatments: Drug: Lenvatinib, tislelizumab, gemcitabine and cisplatin; Drug: gemcitabine and cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05532059

20220901

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

GPLET

Experimental group

Description:

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

Treatment:

Drug: Lenvatinib, tislelizumab, gemcitabine and cisplatin

GP

Active Comparator group

Description:

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

Treatment:

Drug: gemcitabine and cisplatin