Back to resultsLenvatinib, Tislelizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
Primary Purpose
Advanced Cholangiocarcinoma
Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Lenvatinib, tislelizumab, gemcitabine and cisplatin
Gemcitabine and cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Cholangiocarcinoma focused on measuring Lenvatinib, Tislelizumab, Gemcitabine and Cisplatin
Eligibility Criteria
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.
Sites / Locations
- The Second Affiliated Hospital, Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GPLET (Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin)
CG (Gemcitabine and Cisplatin)
Arm Description
Intravenous injection: gemcitabine and cisplatin (CG)+ tislelizumab； Oral administration: lenvatinib.
Intravenous injection: gemcitabine and cisplatin (CG)+placebo； Oral administration: placebo.
Outcomes
Primary Outcome Measures
Objective remission rate (ORR)
The proportion of patients with at least one complete response (CR) or partial response (PR) (%)
Secondary Outcome Measures
Progression-free survival (PFS)
The time between the date of randomization and the date of radiographic progression
Overall survival time (OS)
The time between the date of randomization and death from any cause
Full Information
NCT ID
NCT05823311
First Posted
March 12, 2023
Last Updated
May 5, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
The First Affiliated Hospital of Zhengzhou University, The Affiliated Tumor Hospital of Xinjiang Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05823311
Brief Title
Lenvatinib, Tislelizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
Official Title
A Randomized, Double-blind, Multicenter Study of Lenvatinib, Temalizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
The First Affiliated Hospital of Zhengzhou University, The Affiliated Tumor Hospital of Xinjiang Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cholangiocarcinoma
Keywords
Lenvatinib, Tislelizumab, Gemcitabine and Cisplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GPLET (Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin)
Arm Type
Experimental
Arm Description
Intravenous injection: gemcitabine and cisplatin (CG)+ tislelizumab； Oral administration: lenvatinib.
Arm Title
CG (Gemcitabine and Cisplatin)
Arm Type
Placebo Comparator
Arm Description
Intravenous injection: gemcitabine and cisplatin (CG)+placebo； Oral administration: placebo.
Intervention Type
Drug
Intervention Name(s)
Lenvatinib, tislelizumab, gemcitabine and cisplatin
Intervention Description
Intravenous injection: gemcitabine and cisplatin (CG) + tislelizumab； Oral administration: lenvatinib.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine and cisplatin
Intervention Description
Intravenous injection: gemcitabine and cisplatin (CG) + placebo； Oral administration: placebo.
Primary Outcome Measure Information:
Title
Objective remission rate (ORR)
Description
The proportion of patients with at least one complete response (CR) or partial response (PR) (%)
Time Frame
At the end of 4 treatment cycles(each cycle is 21 days)
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
The time between the date of randomization and the date of radiographic progression
Time Frame
From date of randomization until the date of first documented progression, assessed up to 60 months
Title
Overall survival time (OS)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weilin Wang, doctor
Phone
+86 0571 87783820
Email
wam@zju.edu.cn
Facility Information:
Facility Name
The Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
12. IPD Sharing Statement
Learn more about this trial
Lenvatinib, Tislelizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
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