This prospective, single-arm, multicenter Phase II clinical trial aims to evaluate the efficacy and safety of Benmelstobart plus anlotinib combined with SBRT in patients with oligometastatic hepatocellular carcinoma who have failed first-line targeted therapy. Key study questions include: What is the progression-free survival (PFS) for patients treated with this regimen? How do the objective response rate (ORR), disease control rate (DCR), and overall survival (OS) compare? What are the safety and tolerability profiles of the combination therapy? Eligible subjects (after signing informed consent) will receive anlotinib 10mg on days 1-14 every 3 weeks + Benmelstobart 1200mg on day 1 every 3 weeks + SBRT. Treatment cycles will be 3 weeks long, continuing until a protocol-specified treatment discontinuation event occurs. Following treatment completion, subjects will undergo post-treatment safety follow-up and survival monitoring, with tumor progression monitoring conducted post-treatment.
The patients voluntarily participated in the study, signed the informed consent form, and the compliance was good.
Age >=18 years old, male or female;
Patients with histologically confirmed or clinically diagnosed HCC, and the disease is not suitable for radical surgery;
Patients with oligometastatic HCC who had failed previous target-immunotherapy combined with first-line therapy. Oligometastases are defined as the number of metastatic organs ≤2 and the total number of metastases <=5, and oligometastases are suitable for SBRT treatment.
Known cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, and fibrolamellar cell carcinoma. Other active malignant tumors other than HCC within 5 years or at the same time. The cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, breast cancer in situ, etc., were excluded.
Prior receipt of anlotinib or a non-PD-1 monoclonal antibody immune checkpoint inhibitor;
The time interval between the last target-free drug use and enrollment was less than 3 weeks.
Patients who received previous local treatment (including TACE, ablation, HAIC, or radiotherapy) for the target lesion less than 1 month before enrollment.