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RecruitingPhase 2NCT05532059

Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma

A Phase Ⅱ, Open Label, Single-center Study of Lenvatinib and Tirelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

100 participants

Start Date

Jan 31, 2022

Study Type

INTERVENTIONAL

Conditions

Advanced Cholangiocarcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

  • 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 Criteria5

  • Active or previously documented autoimmune disease or inflammatory disease.
  • Uncontrolled complications.
  • History of other primary malignancies.
  • Active infection.
  • Women who are pregnant or breastfeeding.

Interventions

DRUGLenvatinib, tislelizumab, gemcitabine and cisplatin

Lenvatinib, tislelizumab, gemcitabine and cisplatin

DRUGgemcitabine and cisplatin

gemcitabine and cisplatin

Locations(1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT05532059

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