Phase II Study of Bevacizumab, IparomlimabTuvonralimab, and Hepatic Artery Infusion Chemotherapy Followed by Stereotactic Body Radiotherapy in Adults with Advanced BCLC Stage C Hepatocellular Carcinoma with Portal Vein Tumor Thrombus or Limited Metastases

What this Trial Is About

Researchers are evaluating a new combination treatment for patients with advanced liver cancer known as Barcelona Clinic Liver Cancer BCLC stage C hepatocellular carcinoma HCC, specifically those with portal vein tumor thrombus PVTT or limited spread outside the liver oligometastases. This Phase II study aims to see if combining hepatic artery infusion chemotherapy HAIC with immunotherapy drugs iparomlimabtuvonralimab and bevacizumab, followed by focused radiotherapy, can improve survival and disease control while maintaining quality of life and safety. The treatment includes up to four cycles of HAIC, where chemotherapy drugs are delivered directly into the liver artery over 2-3 days every three weeks. Alongside this, patients receive intravenous bevacizumab every three weeks, followed by iparomlimabtuvonralimab, also every three weeks. After these cycles, patients undergo stereotactic body radiotherapy SBRT delivering 25-40 Gy in 5 sessions over 1-2 weeks to target tumors in the liver, portal vein, or limited extrahepatic lesions. The regimen is designed to act together to reduce tumor burden and enhance immune response. Participants will be closely monitored through various assessments during and after treatment, including imaging to measure tumor response and disease progression over at least two years. Researchers will track progression-free survival as the main outcome, along with overall survival, response rates, disease control, local tumor control, adverse events, and quality of life changes. The study will evaluate safety and treatment-related side effects over five years, with detailed follow-up to assess long-term outcomes of this combined approach.

BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + SBRT for BCLC-C HCC With PVTT and/or Oligometastases