Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
- Conditions
- Advanced Cholangiocarcinoma
- Interventions
- Drug: Lenvatinib, tislelizumab, gemcitabine and cisplatin
- Registration Number
- NCT05823311
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GPLET (Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin) Lenvatinib, tislelizumab, gemcitabine and cisplatin Intravenous injection: gemcitabine and cisplatin (CG)+ tislelizumab； Oral administration: lenvatinib. CG (Gemcitabine and Cisplatin) Gemcitabine and cisplatin Intravenous injection: gemcitabine and cisplatin (CG)+placebo； Oral administration: placebo.
- Primary Outcome Measures
Name Time Method Objective remission rate (ORR) At the end of 4 treatment cycles(each cycle is 21 days) The proportion of patients with at least one complete response (CR) or partial response (PR) (%)
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) From date of randomization until the date of first documented progression, assessed up to 60 months The time between the date of randomization and the date of radiographic progression
Overall survival time (OS) From date of randomization until the date of death from any cause, assessed up to 60 months The time between the date of randomization and death from any cause
Trial Locations
- Locations (1)
The Second Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China