Last reviewed · How we verify
NCT06261125: HSBRT2401
Combination of SBRT, PD-L1 Inhibitor, and Lenvatinib in Hepatocellular Carcinoma (HSBRT2401)
Phase 2 trial testing Stereotactic body radiotherapy in Hepatocellular Carcinoma in 60 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | Mian XI |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 10 March 2024 |
| Primary completion | 30 June 2026 |
| Estimated completion | 30 June 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Stereotactic body radiotherapy
- Adebrelimab — full drug profile →
- Lenvatinib (LENVATINIB) — full drug profile →
Conditions studied
- Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
Sponsor
Mian XI
Who can join
Adults 18 to 75, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Abdominal lymph node metastasis (LNM) is one of the major modes of extrahepatic metastasis in hepatocellular carcinoma (HCC). Immunotherapy targeting the PD-1/PD-L1 checkpoints combined with targeted therapy is the standard treatment for HCC with abdominal LNM, but the outcome remains very poor, with an objective response rate of 5% to 30%. Previous studies have demonstrated that stereotactic body radiotherapy (SBRT) is an effective local treatment for HCC with abdominal LNM, with a high response rate of 60% to 80%. However, intrahepatic dissemination and distant metastasis remains the major recurrence pattern after SBRT in these patients, suggesting radiotherapy should be combined with systematic treatment. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC. The aim of this study was to investigate the efficacy and safety of SBRT followed by adebrelimab (an anti-PD-L1 antibody) and lenvatinib in HCC patients with portal abdominal LNM.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Biomarkers for diagnosis and therapeutic options in hepatocellular carcinoma.
Chan YT, Zhang C, Wu J, Lu P, et al · · 2024 · cited 158× · PMID 39242496 · DOI 10.1186/s12943-024-02101-z -
Application of Immune Checkpoint Inhibitors in Cancer.
Chen Z, Song Z, Den S, Zhang W, et al · · 2025 · cited 2× · PMID 40787068 · DOI 10.1002/mco2.70176 -
Combining External Beam Radiotherapy and Immunotherapy for the Treatment of Hepatocellular Carcinoma.
Le C, Abraham AG, Tankel K, Usmani N, et al · · 2026 · PMID 42041745 · DOI 10.3390/curroncol33040226 -
Treatment of intermediate-to-advanced unresectable hepatocellular carcinoma is shifting toward a multidisciplinary strategy that includes multiple modalities as needed.
Sato K. · · 2025 · PMID 40093678 · DOI 10.3748/wjg.v31.i10.103420
Verify or expand the search:
- PubMed search for NCT06261125
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Hepatocellular Carcinoma
Currently open trials in the same condition.
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- NCT05842174 — Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma · Phase 1, PHASE2 · recruiting
- NCT07417397 — Adjuvant TACE in HCC With High-risk Recurrence Factors · Phase 3 · recruiting
- NCT07317414 — β-alanine in the Treatment of Advanced Hepatocellular Carcinoma · Phase 2 · recruiting
- NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer · Phase 1 · recruiting
Other Mian XI trials
Trials by the same sponsor.
- NCT05557955 — Identification of Breath Biomarkers in Esophageal Cancer · completed
- NCT04167293 — Combination of Sintilimab and Stereotactic Body Radiotherapy in Hepatocellular Carcinoma (ISBRT01) · Phase 2, PHASE3 · unknown
- NCT04005170 — Combination of Toripalimab and Chemoradiotherapy in Esophageal Cancer · Phase 2 · completed
- NCT02403531 — Induction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer · Phase 2 · completed
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 NCT06261125 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mian XI
- Last refreshed: 12 March 2024
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/NCT06261125.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing