Benmelstobart Plus Anlotinib Combined With SBRT for Hepatocellular Carcinoma
Summary
NIH ClinicalTrials.gov registered Phase 2 trial NCT07537777 evaluating Benmelstobart plus anlotinib combined with stereotactic body radiation therapy (SBRT) in patients with oligometastatic hepatocellular carcinoma who have failed first-line targeted therapy. The prospective, single-arm, multicenter study will assess progression-free survival, objective response rate, disease control rate, overall survival, and treatment safety. Eligible patients receive anlotinib 10mg on days 1-14 every 3 weeks plus Benmelstobart 1200mg on day 1 every 3 weeks combined with SBRT.
What changed
This entry registers a new Phase 2 clinical trial (NCT07537777) on ClinicalTrials.gov investigating the combination of Benmelstobart (PD-L1 inhibitor) plus anlotinib (tyrosine kinase inhibitor) with stereotactic body radiation therapy for oligometastatic hepatocellular carcinoma patients who have progressed on first-line targeted therapy. The single-arm multicenter study will evaluate treatment efficacy through progression-free survival, objective response rate, disease control rate, and overall survival, along with safety and tolerability assessments.
Healthcare providers and clinical investigators involved in hepatocellular carcinoma treatment may identify this trial for patient referrals or collaborative research opportunities. Patients who have failed first-line targeted therapy may find this registered trial as a potential treatment option to discuss with their oncologists. The trial represents standard clinical research registration activity on ClinicalTrials.gov with no immediate compliance obligations for healthcare institutions.
Archived snapshot
Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Benmelstobart Plus Anlotinib Combined With SBRT for Patients With Hepatocellular Carcinoma Failing First-Line Targeted Therapy
Phase 2 NCT07537777 Kind: PHASE2 Apr 17, 2026
Abstract
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.
Conditions: Hepatocellular Carcinoma (HCC), First-line Targeted Therapy Failure, Oligometastatic Hepatocellular Carcinoma, Benmelstobart, Anlotinib, SBRT
Interventions: Benmelstobart, SBRT, Anlotinib
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