Trials / Not Yet Recruiting
Not Yet RecruitingNCT07537777
Benmelstobart Plus Anlotinib Combined With SBRT for Patients With Hepatocellular Carcinoma Failing First-Line Targeted Therapy
Benmelstobart Plus Anlotinib Combined With SBRT for Patients With Hepatocellular Carcinoma Failing First-Line Targeted Therapy:A Single-Arm, Multicenter Clinical Study
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (estimated)
- Sponsor
- Nanfang Hospital, Southern Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
| Type | Name | Description |
|---|---|---|
| DRUG | Benmelstobart | Benmelstobart will be administered at a dose of 1200mg on day 1 via intravenous infusion, once every 3 weeks. The maximum cumulative treatment duration shall be 2 years. |
| PROCEDURE | SBRT | SBRT 50Gy/5F |
| DRUG | Anlotinib | Aronitin 10mg orally on days 1-14 every 3 weeks, with one treatment cycle defined as 3 weeks. The maximum cumulative treatment duration shall be 2 years. |
Timeline
- Start date
- 2026-04-20
- Primary completion
- 2028-01-31
- Completion
- 2028-08-31
- First posted
- 2026-04-17
- Last updated
- 2026-04-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07537777. Inclusion in this directory is not an endorsement.