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

Advanced Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823311
• Other study ID #: 2023-0175
• Status: Recruiting
• Phase: Phase 3
• Start date: October 31, 2023
• Est. completion date: December 30, 2028

Study information

• Verified date: March 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Weilin Wang, doctor
• Phone: +86 0571 87783820
• Email: wam[@]zju.edu.cn
• 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, the study aims 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: 80
• Est. completion date: December 30, 2028
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients.
• Expected survival period > 12 weeks.
• The World Health Organization (WHO) / ECOG physical status (PS) was 0 or 1.
• There was at least one target lesion that matched the RECIST 1.1 criteria at baseline.
• 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: Hemoglobin (Hb)=9.0g/dL; Neutrophils (ANC) = 1.5* 10^9/L; Platelet (Pt) = 50*10^9/L; ALT=2.5×ULN(Normal upper limit); AST=2.5×ULN.
• Voluntary participation and signing of informed consent.

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.
• Patients with severe allergic history or specific constitution.
• Researchers consider it inappropriate to participate in the test.

Related Conditions & MeSH terms

• Advanced Cholangiocarcinoma
• Cholangiocarcinoma

Intervention

Drug:
• Lenvatinib, tislelizumab, gemcitabine and cisplatin
Intravenous injection: gemcitabine and cisplatin (CG) + tislelizumab; Oral administration: lenvatinib.
• Gemcitabine and cisplatin
Intravenous injection: gemcitabine and cisplatin (CG) + placebo; Oral administration: placebo.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	The Affiliated Tumor Hospital of Xinjiang Medical University, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective remission rate (ORR)	The proportion of patients with at least one complete response (CR) or partial response (PR) (%)	At the end of 4 treatment cycles(each cycle is 21 days)
Secondary	Progression-free survival (PFS)	The time between the date of randomization and the date of radiographic progression	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