Combination treatment for advanced cholangiocarcinoma
A Randomized, Double-blind, Multicenter Study of Lenvatinib, Temalizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
This study is testing a new combination of four drugs to see if it can help people with advanced cholangiocarcinoma feel better and improve their treatment results.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | immunotherapy, Tislelizumab, Lenvatinib, chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05823311 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of a combination therapy using Lenvatinib, Tislelizumab, Gemcitabine, and Cisplatin for patients with advanced cholangiocarcinoma. The approach aims to leverage the synergistic effects of targeted therapy and immunotherapy to combat this aggressive cancer. By targeting the tumor microenvironment and enhancing anti-tumor immune responses, the study seeks to improve treatment outcomes for patients who are typically diagnosed at an advanced stage. Participants will receive the treatment regimen and be monitored for safety and efficacy outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically proven, unresectable advanced or metastatic cholangiocarcinoma who have not previously received immunotherapy.
Not a fit: Patients with active autoimmune diseases, uncontrolled complications, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced cholangiocarcinoma, potentially improving survival rates and quality of life.
How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies and immunotherapies in various cancers, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Weilin Wang, doctor
- Email: wam@zju.edu.cn
- Phone: +86 0571 87783820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.