Advanced Cholangiocarcinoma
Conditions
Keywords
Lenvatinib; Gemcitabine and Cisplatin; Tislelizumab; Cholangiocarcinoma
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,we aim to investigate the safety and efficacy of lenvatinib, tislelizumab combined with gemcitabine plus cisplatin (GPLET) in the treatment of advanced cholangiocarcinoma.
Interventions
Lenvatinib, tislelizumab, gemcitabine and cisplatin
DRUGgemcitabine and cisplatin
gemcitabine and cisplatin
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective remission rate (ORR) | 4 cycle treatment (each cycle is 21 days) | According to RECIST v1.1, the proportion of patients with at least one complete response (CR) or partial response (PR) (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 as defined by RECIST1.1 |
| 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 |
Countries
China
Outcome results
None listed