To hear about similar clinical trials, please enter your email below
Trial Title:
Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients With Advanced Cholangiocarcinoma
NCT ID:
NCT05532059
Condition:
Advanced Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Cisplatin
Gemcitabine
Lenvatinib
Tislelizumab
Conditions: Keywords:
Lenvatinib; Gemcitabine and Cisplatin; Tislelizumab; Cholangiocarcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lenvatinib, tislelizumab, gemcitabine and cisplatin
Description:
Lenvatinib, tislelizumab, gemcitabine and cisplatin
Arm group label:
GPLET
Intervention type:
Drug
Intervention name:
gemcitabine and cisplatin
Description:
gemcitabine and cisplatin
Arm group label:
GP
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 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:
January 31, 2022
Completion date:
August 31, 2028
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang 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/NCT05532059
