Phase II Study of QL1706 Iparomlimab and Tuvonralimab with Bevacizumab and RALOX Hepatic Arterial Infusion Chemotherapy for Liver Cancer Patients with VP34 Portal Vein Tumor Thrombosis

What this Trial Is About

Researchers are evaluating a combination therapy for liver cancer patients who have a specific type of tumor growth called VP34 portal vein tumor thrombus. This Phase II clinical trial aims to assess the clinical effectiveness and safety of a treatment combining QL1706, bevacizumab, and RALOX hepatic artery infusion chemotherapy. The study will also explore molecular biomarkers to predict how well patients respond to this combined therapy. Participants will receive QL1706 by intravenous infusion at a dose of 7.5 mgkg every 3 weeks, along with bevacizumab at 15 mgkg intravenously every 3 weeks. The RALOX chemotherapy regimen, which includes oxaliplatin and raltitrexed, will be delivered directly into the liver artery using a catheter and infusion pump. Treatment cycles last 3 weeks, and therapy may continue for up to 2 years, or until specific stopping criteria are met. After treatment ends, participants will have follow-up visits to monitor safety, survival, and tumor progression if treatment is stopped for reasons other than disease progression or death. During the study, participants will undergo various assessments including imaging to measure tumor lesions, blood tests to monitor organ function and safety, and evaluations of their overall health status and survival. Researchers will measure progression-free survival as the main outcome, along with response rates, disease control, overall survival, and treatment-related side effects. The entire study participation may last up to about 2 years, including treatment and follow-up periods.

QL1706 in Combination With Bevacizumab and RALOX HAIC for Hepatocellular Carcinoma With Vp3/4 PVTT