Combining Lenvatinib, Tislelizumab, Gemcitabine, and Cisplatin for Advanced Cholangiocarcinoma
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
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT05532059 · Data updated 2026-11-12
This study is testing a new combination of four cancer drugs to see if it can help people with advanced bile duct cancer feel better and have more treatment options.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Drugs / interventions | immunotherapy, tislelizumab, lenvatinib, chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | January 31, 2022 |
| Main results expected | August 31, 2025 |
| Study ends | August 31, 2028 |
| Registry record updated | February 10, 2025 |
| Trial ID | NCT05532059 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with histologically confirmed unresectable advanced or metastatic cholangiocarcinoma who have not previously received immunotherapy.
✕Probably not a fit
Patients with active autoimmune diseases, uncontrolled complications, or other primary malignancies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the safety and efficacy of a combination treatment involving lenvatinib, tislelizumab, gemcitabine, and cisplatin in patients with advanced cholangiocarcinoma, a type of cancer affecting the bile ducts. The approach aims to leverage the synergistic effects of targeted therapy and immunotherapy to enhance anti-tumor responses. Patients with unresectable advanced or metastatic cholangiocarcinoma will be enrolled, and their responses to the treatment will be monitored according to RECIST criteria. The study seeks to provide a new therapeutic option for patients who have limited treatment choices.
Why it matters
Potential benefit: If successful, this treatment could offer a new effective option for patients with advanced cholangiocarcinoma, potentially improving survival rates and quality of life.
How similar studies have gone: While the combination of targeted therapies and immunotherapy is a promising approach, the specific combination being tested in this trial has not been widely studied, making it a novel investigation.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.