Neoplasms

All Conditions

Rare Diseases

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Lenvatinib

Tislelizumab

Cisplatin

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

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

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

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

Lenvatinib, tislelizumab, gemcitabine and cisplatin

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

Gemcitabine and cisplatin

Weilin Wang, doctor

weilin wang, doctor

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.

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

A Randomized, Double-blind, Multicenter Study of Lenvatinib, Temalizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma

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

The time between the date of randomization and the date of radiographic progression

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

The First Affiliated Hospital of Zhengzhou University

The Affiliated Tumor Hospital of Xinjiang Medical University

Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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

gemcitabine and cisplatin

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.

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

A Phase Ⅱ, Open Label, Single-center Study of Lenvatinib and Tirelizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lenvatinib, Tislelizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma	NCT05823311	Advanced Cholan...	Lenvatinib, tis... Gemcitabine and...	18 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Lenvatinib, Tislelizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma	NCT05823311	Advanced Cholan...	Lenvatinib, tis... Gemcitabine and...	18 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients With Advanced Cholangiocarcinoma	NCT05532059	Advanced Cholan...	Lenvatinib, tis... gemcitabine and...	18 Years - 85 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University

Spots Global Cancer Trial Database for lenvatinib, tislelizumab, gemcitabine and cisplatin