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NCT07537777
Benmelstobart Plus Anlotinib Combined With SBRT for Patients With Hepatocellular Carcinoma Failing First-Line Targeted Therapy
Phase 2 trial testing Benmelstobart in Hepatocellular Carcinoma (HCC) in 29 participants. Not yet recruiting.
31 January 2028
Quick facts
| Lead sponsor | Nanfang Hospital, Southern Medical University |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 29 |
| Start date | 20 April 2026 |
| Primary completion | 31 January 2028 |
| Estimated completion | 31 August 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Benmelstobart — full drug profile →
- SBRT — full drug profile →
- Anlotinib — full drug profile →
Conditions studied
- Hepatocellular Carcinoma (HCC) — all drugs for Hepatocellular Carcinoma (HCC) →
- First-line Targeted Therapy Failure — all drugs for First-line Targeted Therapy Failure →
- Oligometastatic Hepatocellular Carcinoma — all drugs for Oligometastatic Hepatocellular Carcinoma →
- Benmelstobart — all drugs for Benmelstobart →
Sponsor
Nanfang Hospital, Southern Medical University
Who can join
18 and older, any sex, with Hepatocellular Carcinoma (HCC) or First-line Targeted Therapy Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07537777
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Currently open trials in the same condition.
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Other Nanfang Hospital, Southern Medical University trials
Trials by the same sponsor.
- NCT07091994 — A Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy · Phase 4 · not yet recruiting
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- NCT07481032 — Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients · NA · not yet recruiting
- NCT07511894 — Beta-Blockers on the Efficacy of Neoadjuvant Immunotherapy for Gastric Cancer · Phase 2 · not yet recruiting
- NCT07452055 — Large Language Model-Based Emotional Management for Breast Cancer Patients · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07537777 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nanfang Hospital, Southern Medical University
- Last refreshed: 17 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07537777.
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