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

Phase 2RecruitingNCT05532059

Second Affiliated Hospital, School of Medicine, Zhejiang University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Advanced Cholangiocarcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

objective remission rate (ORR)

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

Time frame: 4 cycle treatment (each cycle is 21 days)

Secondary Outcomes

progression-free survival (PFS)

The time between the date of randomization and the date of radiographic progression as defined by RECIST1.1

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

Overall survival time (OS)

The time between the date of randomization and death from any cause

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