Bevacizumab Plus QL1706 Combined With Stereotactic Body Radiotherapy in Patients With BCLC Stage C Hepatocellular Carcinoma With Portal Vein Tumor Thrombus or Extrahepatic Oligometastatic Metastases (BRAVE): A Prospective, Multicenter, Single-Arm Phase II Study
This multicenter, prospective, single-arm Phase II clinical trial is designed to evaluate the efficacy and safety of combining bevacizumab and QL1706 with stereotactic body radiotherapy (SBRT) in patients with Barcelona Clinic Liver Cancer (BCLC) stage C hepatocellular carcinoma (HCC) who present with portal vein tumor thrombus (PVTT) or extrahepatic oligometastatic disease. The study aims to determine whether this combination strategy can prolong progression-free survival (PFS), while also improving overall survival (OS), objective response rate (ORR), disease control rate (DCR), and duration of response (DoR), as well as maintaining quality of life (QoL). In addition, the trial will systematically evaluate the safety profile and treatment-related toxicities associated with this regimen.
• Male or female patients aged between 18 and 70 years.
• Histologically confirmed or clinically diagnosed HCC based on the 2024 Guidelines for Diagnosis and Treatment of Primary Liver Cancer issued by the National Health Commission of the Peoples Republic of China.
• BCLC stage C disease, with either PVTT and/or extrahepatic oligometastases. Oligometastases are defined as≤5 metastatic lesions involving≤3 organs.
• Liver function classified as Child-Pugh class A or B (score≤7).
• At least one measurable lesion according to RECIST v1.1: defined as a lesion with a longest diameter \>1.5 cm, or ≥1 lesion with a longest diameter \>1.0 cm and at least two perpendicular diameters measurable.
• ECOG performance status score ≤2.
• Expected survival time ≥3 months.
• Adequate organ function (liver, kidney, lung, and heart) to tolerate both local radiotherapy and systemic therapy.
• Patients of reproductive potential must agree to use reliable contraception during the study and for at least 12 months after the end of treatment.
⁃ Ability to understand and voluntarily sign written informed consent prior to initiation of any study-specific procedures.