Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma
Recruiting now · Phase 2
Conditions studied: Advanced Cholangiocarcinoma
In brief
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.
Key facts
- Study ID
- NCT05532059
- Run by
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- People needed
- 100
- Starts
- 2022-01-31
- Expected to finish
- 2028-08-31
- Last updated by the study team
- 2025-02-10
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Active or previously documented autoimmune disease or inflammatory disease.
- Uncontrolled complications.
- History of other primary malignancies.
- Active infection.
- Women who are pregnant or breastfeeding.
Where it is running
- The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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