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NCT05608213
Lenvatinib Plus I-125 Seed Brachytherapy vs. Lenvatinib for TACE-refractory HCC
Phase 3 trial testing Lenvatinib Plus I-125 Seed Brachytherapy in Hepatocellular Carcinoma Non-resectable in 187 participants. Currently enrolling.
31 October 2026
Quick facts
| Lead sponsor | Second Affiliated Hospital of Guangzhou Medical University |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 187 |
| Start date | 2 November 2022 |
| Primary completion | 31 October 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Lenvatinib Plus I-125 Seed Brachytherapy
- Lenvatinib (LENVATINIB) — full drug profile →
Conditions studied
- Hepatocellular Carcinoma Non-resectable — all drugs for Hepatocellular Carcinoma Non-resectable →
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
Who can join
Adults 18 to 75, any sex, with Hepatocellular Carcinoma Non-resectable. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is conducted to evaluate the efficacy and safety of lenvatinib plus iodine-125 seed brachytherapy (Len-I) compared with lenvatinib (Len) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Hepatocellular carcinoma: signaling pathways and therapeutic advances.
Zheng J, Wang S, Xia L, Sun Z, et al · · 2025 · cited 142× · PMID 39915447 · DOI 10.1038/s41392-024-02075-w -
Tyrosine-kinase inhibitor combined with iodine-125 seed brachytherapy for hepatocellular carcinoma refractory to transarterial chemoembolization: a propensity-matched study.
Guo Y, Wu J, Liang L, Zhu K, et al · · 2023 · cited 4× · PMID 37749616 · DOI 10.1186/s40644-023-00604-4
Verify or expand the search:
- PubMed search for NCT05608213
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hepatocellular Carcinoma Non-resectable
Currently open trials in the same condition.
- NCT06904183 — Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT · Phase 2 · recruiting
- NCT06904196 — Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC · Phase 2 · recruiting
- NCT06561399 — Triple Therapy Sequential Radiotherapy in Unresectable HCC (TALENP003) · recruiting
- NCT06492395 — Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT · Phase 3 · recruiting
- NCT06397235 — DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC · Phase 2 · recruiting
Other Second Affiliated Hospital of Guangzhou Medical University trials
Trials by the same sponsor.
- NCT06966830 — Lacosamide Intravenous Injection for Emergency Termination of Status Epilepticus · not yet recruiting
- NCT06936683 — Herpes Simplex Virus Type 1 Infection/Reactivation of Patients With Severe Pneumonia(the HSV-SP Study) · not yet recruiting
- NCT07374328 — Triple Hypoglycemic Regimens In Patients With Newly Diagnosed Type 2 Diabetes Mellitus · Phase 1, PHASE2 · recruiting
- NCT06904183 — Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT · Phase 2 · recruiting
- NCT06904196 — Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC · Phase 2 · 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 NCT05608213 (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 Second Affiliated Hospital of Guangzhou Medical University
- Last refreshed: 8 November 2022
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/NCT05608213.
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