NCT05823311 Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
| NCT ID | NCT05823311 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Advanced Cholangiocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 80 participants in total. It began in 2023-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, the study aims to investigate the safety and efficacy of Lenvatinib, Tislelizumab combined with Gemcitabine plus Cisplatin (GPLET) in the treatment of advanced cholangiocarcinoma.
Eligibility Criteria
Inclusion Criteria: * Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients. * Expected survival period \> 12 weeks. * The World Health Organization (WHO) / ECOG physical status (PS) was 0 or 1. * There was at least one target lesion that matched the RECIST 1.1 criteria at baseline. * 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: Hemoglobin (Hb)≥9.0g/dL; Neutrophils (ANC) ≥ 1.5\* 10\^9/L; Platelet (Pt) ≥ 50\*10\^9/L; ALT≤2.5×ULN（Normal upper limit); AST≤2.5×ULN. * Voluntary participation and signing of informed consent. 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. * Patients with severe allergic history or specific constitution. * Researchers consider it inappropriate to participate in the test.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05823311 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Cholangiocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05823311 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 80 participants.
Is NCT05823311 currently recruiting?
Yes, NCT05823311 is actively recruiting participants. Contact the research team at wam@zju.edu.cn for enrollment information.
Where is the NCT05823311 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05823311 clinical trial?
NCT05823311 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 80 participants.