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

Advanced Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05532059
• Other study ID #: 20220901
• Status: Recruiting
• Phase: Phase 2
• Start date: January 31, 2022
• Est. completion date: August 31, 2028

Study information

• Verified date: October 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2028
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cholangiocarcinoma
• Cholangiocarcinoma

Intervention

Drug:
• Lenvatinib, tislelizumab, gemcitabine and cisplatin
Lenvatinib, tislelizumab, gemcitabine and cisplatin
• gemcitabine and cisplatin
gemcitabine and cisplatin

Locations

Country	Name	City	State
China	The Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	progression-free survival (PFS)	The time between the date of randomization and the date of radiographic progression as defined by RECIST1.1	From date of randomization until the date of first documented progression, assessed up to 60 months
Secondary	Overall survival time (OS)	The time between the date of randomization and death from any cause	From date of randomization until the date of death from any cause, assessed up to 60 months