drugset / Trial / NCT07776080

Iparomlimab and Tuvonralimab With Lenvatinib, Radiotherapy, and HAIC for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

NCT07776080 ↗

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to learn how well a combination of iparomlimab and tuvonralimab (QL1706), lenvatinib, radiotherapy, and hepatic arterial infusion chemotherapy (HAIC) works and how safe it is for people with hepatocellular carcinoma (HCC) that has grown into the portal vein, forming a portal vein tumor thrombus (PVTT). Participants will receive iparomlimab and tuvonralimab together with lenvatinib, radiotherapy directed at the portal vein tumor thrombus, and HAIC, which delivers chemotherapy directly through the hepatic artery. Researchers will evaluate how long the cancer remains controlled without getting worse, how much the tumors shrink, how long participants survive, and whether the treatment makes surgery possible for some participants. Treatment-related side effects will also be assessed. The study will also explore whether features in tumor tissue and blood are associated with treatment response and may help identify patients who are more likely to benefit from this treatment strategy.

Timeline

Start
2026-10-01
Primary completion
2027-10-01
Completion
2028-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Iparomlimab Monoclonal antibody — Intravenous
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Tuvonralimab Monoclonal antibody — Intravenous