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Trial Title:
Lenvatinib, Tislelizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
NCT ID:
NCT05823311
Condition:
Advanced Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Cisplatin
Gemcitabine
Lenvatinib
Tislelizumab
Conditions: Keywords:
Lenvatinib
Tislelizumab
Gemcitabine and Cisplatin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Care Provider)
Intervention:
Intervention type:
Drug
Intervention name:
Lenvatinib, tislelizumab, gemcitabine and cisplatin
Description:
Intravenous injection: gemcitabine and cisplatin (CG) + tislelizumab； Oral
administration: lenvatinib.
Arm group label:
GPLET (Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin)
Intervention type:
Drug
Intervention name:
Gemcitabine and cisplatin
Description:
Intravenous injection: gemcitabine and cisplatin (CG) + placebo； Oral administration:
placebo.
Arm group label:
CG (Gemcitabine and Cisplatin)
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Recruiting
Contact:
Last name:
weilin wang, doctor
Phone:
+86 0571 87783820
Email:
wam@zju.edu.cn
Start date:
October 31, 2023
Completion date:
December 30, 2028
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Collaborator:
Agency:
The Affiliated Tumor Hospital of Xinjiang Medical University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05823311
