Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lenvatinib, tislelizumab, gemcitabine and cisplatin, gemcitabine and cisplatin.
- Who it may be relevant to
- Registry conditions: Advanced Cholangiocarcinoma. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Drug Lenvatinib, tislelizumab, gemcitabine and cisplatin
Lenvatinib, tislelizumab, gemcitabine and cisplatin - Drug gemcitabine and cisplatin
gemcitabine and cisplatin
Primary outcome measures
- objective remission rate (ORR) [Time frame: 4 cycle treatment (each cycle is 21 days)]
Secondary outcome measures (2)
- progression-free survival (PFS) [Time frame: From date of randomization until the date of first documented progression, assessed up to 60 months]
- Overall survival time (OS) [Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT05532059 · 20220901