Phase 2 Study of Radiation Therapy with Tislelizumab and Regorafenib for Patients with Unresectable or Limited Spread Liver Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining stereotactic body radiation therapy SBRT with immunotherapy and targeted therapy for patients who have unresectable or limited spread oligometastatic hepatocellular carcinoma HCC. This phase 2 clinical trial aims to determine whether this combination can extend the time patients live without their disease worsening. The main focus is on progression-free survival PFS as a key outcome. Participants will receive SBRT to all visible tumors, with doses of 8 Gy given in 3 to 5 sessions. Alongside radiation, they will start systemic treatment with two drugs, tislelizumab and regorafenib, which will continue for up to 2 years or until the disease progresses, side effects become intolerable, or death occurs. Tislelizumab is administered every 21 days at a fixed dose, while regorafenib is taken for 21 days in each 28-day cycle, with possible dose adjustments for side effects. During the study, participants will be closely monitored with medical assessments to track disease status and side effects. Researchers will measure progression-free survival up to 48 months after treatment starts, along with overall survival and patterns of disease recurrence. The trial began in June 2023 and is expected to end in December 2026, offering long-term follow-up to assess outcomes and safety.

Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC