BRAVE Study: QL1706 + Bevacizumab + SBRT for BCLC-C HCC With PVTT or Oligometastases

Launched by SHANDONG CANCER HOSPITAL AND INSTITUTE · Jul 11, 2025

Keywords

ClinConnect Summary

This clinical trial, called the BRAVE Study, is exploring a new treatment approach for people with advanced liver cancer (hepatocellular carcinoma) who have cancer growing into the main vein of the liver (portal vein tumor thrombus) or a small number of cancer spots outside the liver (oligometastases). The study is testing a combination of two medicines—QL1706, an immunotherapy drug that helps the immune system fight cancer, and bevacizumab, which blocks blood vessels that feed tumors—along with a focused form of radiation therapy called stereotactic body radiotherapy (SBRT). The goal is to see if this combination can help control the cancer for longer, improve survival, and maintain quality of life, while also checking how safe the treatment is.

Adults between 18 and 70 years old with advanced liver cancer that fits specific criteria may be eligible to join. To qualify, patients must have reasonably good liver function and overall health, and their cancer must meet certain size and spread limits. Participants can expect to receive the combined treatment and regular monitoring to track the cancer’s response and any side effects. This study is currently recruiting patients and aims to find out if this new treatment plan offers better outcomes than current options for people with this serious form of liver cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients aged between 18 and 70 years.
• • 2. 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 People"s Republic of China.
• • 3. BCLC stage C disease, with either PVTT and/or extrahepatic oligometastases. Oligometastases are defined as≤5 metastatic lesions involving≤3 organs.
• • 4. Liver function classified as Child-Pugh class A or B (score≤7).
• • 5. 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.
• • 6. ECOG performance status score ≤2.
• • 7. Expected survival time ≥3 months.
• • 8. Adequate organ function (liver, kidney, lung, and heart) to tolerate both local radiotherapy and systemic therapy.
• • 9. Patients of reproductive potential must agree to use reliable contraception during the study and for at least 12 months after the end of treatment.
• • 10. Ability to understand and voluntarily sign written informed consent prior to initiation of any study-specific procedures.
• Exclusion Criteria:
• • 1. Presence of a second primary malignancy.
• • 2. BCLC stage C patients not meeting the criteria for oligometastases.
• • 3. Presence of brain metastases or peritoneal carcinomatosis.
• • 4. PVTT or metastatic lesions not amenable to radiotherapy.
• • 5. Prior chemotherapy or systemic anticancer therapy.
• • 6. Severe impairment of liver, kidney, lung, or cardiac function that would preclude tolerating radiotherapy or systemic treatment.
• • 7. Serious medical comorbidities that may interfere with study participation, including but not limited to uncontrolled diabetes, active peptic ulcer disease, or other significant cardiopulmonary conditions (as judged by the investigator).
• • 8. Severe or uncontrolled infections, or active autoimmune diseases.
• • 9. Neurological disorders affecting central nervous system function.
• • 10. Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception.
• • 11. Known allergy or hypersensitivity to any of the study drugs.
• • 12. Patients deemed unsuitable for the study for any other reason at the discretion of the investigator.thrombus (PVTT), and/or limited extrahepatic lesions