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NCT05250843
TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Intermediate-stage HCC
Phase 2, PHASE3 trial testing TACE/HAIC in Hepatocellular Carcinoma in 90 participants. Status unknown.
30 December 2023
Quick facts
| Lead sponsor | Third Affiliated Hospital, Sun Yat-Sen University |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 30 May 2022 |
| Primary completion | 30 December 2023 |
| Estimated completion | 30 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- TACE/HAIC
- Lenvatinib (LENVATINIB) — full drug profile →
- Sintilimab — full drug profile →
- liver resection
Conditions studied
- Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Who can join
Adults 18 to 70, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the study is to observe the effect of TACE/HAIC combined with lenvatinib and sintilimab as a neoadjuvant therapy before liver resection in preventing the recurrence in high-risk patients with hepatocellular carcinoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immunosuppressive tumor microenvironment and immunotherapy of hepatocellular carcinoma: current status and prospectives.
Shen KY, Zhu Y, Xie SZ, Qin LX. · · 2024 · cited 140× · PMID 38679698 · DOI 10.1186/s13045-024-01549-2 -
Overcoming resistance to immune checkpoint inhibitors in hepatocellular carcinoma: Challenges and opportunities.
Xie Q, Zhang P, Wang Y, Mei W, et al · · 2022 · cited 26× · PMID 36119533 · DOI 10.3389/fonc.2022.958720 -
Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898 -
Neoadjuvant systemic therapy for hepatocellular carcinoma.
Chick RC, Ruff SM, Pawlik TM. · · 2024 · cited 16× · PMID 38495884 · DOI 10.3389/fimmu.2024.1355812 -
Next-Generation Immunotherapy for Hepatocellular Carcinoma: Mechanisms of Resistance and Novel Treatment Approaches.
Eghbali S, Heumann TR. · · 2025 · cited 11× · PMID 39858016 · DOI 10.3390/cancers17020236 -
Locoregional therapies for hepatocellular carcinoma: The current status and future perspectives.
Chen JJ, Chen JJ, Jin ZC, Zhong BY, et al · · 2024 · cited 8× · PMID 38372444 · DOI 10.1002/ueg2.12554 -
Triple combination of HAIC-FO plus tyrosine kinase inhibitors and immune checkpoint inhibitors for advanced hepatocellular carcinoma: A systematic review and meta-analysis.
Tan Z, Zhang J, Xu L, Wang H, et al · · 2023 · cited 7× · PMID 37844117 · DOI 10.1371/journal.pone.0290644 -
Current Perspectives on Perioperative Combination Therapy for Hepatocellular Carcinoma.
Nishio T, Yoh T, Nishino H, Ogiso S, et al · · 2025 · cited 5× · PMID 40528897 · DOI 10.1159/000546138
Verify or expand the search:
- PubMed search for NCT05250843
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 Third Affiliated Hospital, Sun Yat-Sen University trials
Trials by the same sponsor.
- NCT07409259 — PT-MSCs Exosome Injection in the Treatment of Chronic-to-acute Liver Failure · EARLY_PHASE1 · active not recruiting
- NCT07281664 — Transarterial Chemoembolization With Low-Dose Bevacizumab Plus Atezolizumab as First-Line Treatment for Unresectable Hep · NA · not yet recruiting
- NCT07338552 — Effectiveness of a Virtual Health Management Community (VHMC) for Pre-diabetes in China · NA · not yet recruiting
- NCT07354997 — Establishing a Virtual Health Community Management Model for Pre-Diabetes Patients · NA · completed
- NCT07253233 — Treatment of Spinal Cord Injury Using Autologous Concentrated Growth Factors · EARLY_PHASE1 · 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 NCT05250843 (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 Third Affiliated Hospital, Sun Yat-Sen University
- Last refreshed: 13 October 2023
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/NCT05250843.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing