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NCT05532059 | RECRUITING | Advanced Cholangiocarcinoma

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

Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Condition or disease

Advanced Cholangiocarcinoma

Intervention/treatment

Lenvatinib, tislelizumab, gemcitabine and cisplatin

gemcitabine and cisplatin

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase Ⅱ, Open Label, Single-center Study of Lenvatinib and Tirelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
Actual Study Start Date : 2022-01-31
Estimated Primary Completion Date : 2025-08-31
Estimated Study Completion Date : 2028-08-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma

Location Details

NCT05532059

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Locations

RECRUITING

China, Zhejiang

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310009