Lenvatinib Plus Tislelizumab With or Without Gefitinib for Advanced Liver Cancer
Summary
This study is for people with unresectable or advanced hepatocellular carcinoma who have not received previous systemic treatment for liver cancer. The study will compare lenvatinib plus tislelizumab with or without gefitinib. Participants will be randomly assigned to receive either lenvatinib, tislelizumab, and gefitinib, or lenvatinib and tislelizumab. The study is open-label, so participants and study doctors will know the treatment group. The main outcomes are progression-free survival and the number of participants with adverse events of special interest. Progression-free survival is the time from randomization until the cancer gets worse or the participant dies. Adverse events of special interest are predefined side effects that require close monitoring. The study will also evaluate tumor response, overall survival, other side effects, and exploratory biomarkers.
Timeline
- Start
- 2026-11
- Primary completion
- 2026-11
- Completion
- 2028-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gefitinib | Small molecule | 250 mg | Oral |
| Background | Lenvatinib | Small molecule | 8 mg | Oral |
| Background | Lenvatinib | Small molecule | 12 mg | Oral |
| Background | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |