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NCT03469479
Neoadjuvant HAIC for Resectable Hepatocellular Carcinoma Beyond Milan Criteria
Phase 3 trial testing FOLFOX in Hepatocellular Carcinoma in 252 participants. Status unknown.
2 March 2023
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 252 |
| Start date | 2 March 2018 |
| Primary completion | 2 March 2023 |
| Estimated completion | 2 March 2023 |
| Sites | 7 locations across China |
Drugs / interventions tested
- FOLFOX (folfox) — full drug profile →
- Hepatic resection
Conditions studied
- Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
Sponsor
Sun Yat-sen University
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
The purpose of this study is to evaluate the efficacy and safety of resection plus neoadjuvant hepatic arterial infusion chemotherapy (HAIC) compared with resection alone in patients with resectable hepatocellular carcinoma beyond Milan criteria.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Assessment of pegylated arginine deiminase and modified FOLFOX6 in patients with advanced hepatocellular carcinoma: Results of an international, single-arm, phase 2 study.
Harding JJ, Yang TS, Chen YY, Feng YH, et al · · 2021 · cited 12× · PMID 34415578 · DOI 10.1002/cncr.33870 -
Hepatic Artery Infusion Chemotherapy for Primary and Secondary Malignancies of the Liver: State of the Art and Current High-Level Evidence.
Kuemmerli C, Hess V, Dutkowski P, Sinz S, et al · · 2024 · cited 3× · PMID 38368862 · DOI 10.1159/000537887
Verify or expand the search:
- PubMed search for NCT03469479
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07323576 — A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX o · Phase 2 · withdrawn
- NCT07221357 — A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combinat · Phase 2, PHASE3 · recruiting
- NCT07192185 — Systemic Chemotherapy With FOLFOX Plus Atezolizumab & Bevacizumab for Patients With Advanced HCC Who Previously Received · Phase 2 · recruiting
Other recruiting trials for Hepatocellular Carcinoma
Currently open trials in the same condition.
- NCT06902246 — Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma · Phase 2 · recruiting
- 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 Sun Yat-sen University trials
Trials by the same sponsor.
- NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
- NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
- NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
- NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
- NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · 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 NCT03469479 (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 Sun Yat-sen University
- Last refreshed: 2 August 2018
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/NCT03469479.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing