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

Summary

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.

Eligibility

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

Conditions9

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