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NCT03591705
TACE-HAIC vs. HAIC for Potentially Resectable HCC
NA trial testing TACE-HAIC in Potentially Resection in 240 participants. Status unknown.
30 December 2023
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 6 July 2018 |
| Primary completion | 30 December 2023 |
| Estimated completion | 30 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
Conditions studied
- Potentially Resection — all drugs for Potentially Resection →
- Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
Sponsor
Sun Yat-sen University
Who can join
Adults 18 to 75, any sex, with Potentially Resection or Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, due to large tumors, surgical treatment is suitable for early-stage and well-reserved liver function patients. Therefore, in clinical practice, transarterial chemoembolization (TACE) is a preferential and standard treatment of potentially resectable HCC. EACH trial opened the door to FOLFOX-based system chemotherapy for advanced HCC patients. Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for HCC patients. Several clinical studies showed that HAIC bring better tumor response rate that the conditional TACE. The combination of TACE with HAIC (TACE-HAIC), theoretically can significantly increase the local doses of chemotherapeutic agents in the liver, reduce the viability of HCC cells and increase the hepatectomy rate. However, this hasn't been verified in clinical application. To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to compare the safety and efficacy between HAIC and TACE-HAIC for those patients.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Conversion to Resectability Using Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy for Initially Unresectable Hepatocellular Carcinoma.
Li B, Qiu J, Zheng Y, Shi Y, et al · · 2021 · cited 60× · PMID 37636551 · DOI 10.1097/as9.0000000000000057 -
Neoadjuvant Therapy for Hepatocellular Carcinoma.
Yin Z, Chen D, Liang S, Li X. · · 2022 · cited 22× · PMID 36068876 · DOI 10.2147/jhc.s357313 -
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 NCT03591705
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TACE-HAIC
Trials testing the same drug.
- NCT05535998 — TACE-HAIC Combined With TKIs and Immunotherapy Versus TACE Alone for Hepatocellular Carcinoma With PVTT · completed
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 NCT03591705 (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: 22 September 2021
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/NCT03591705.
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