Clinical trial · Interventional
HAIC Versus TACE for Large Hepatocellular Carcinoma Staged BCLC A/B.
The Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Compared With Transarterial Chemoembolization as Initial Treatment in Patients With Large Hepatocellular Carcinoma Staged BCLC A/B.
NCT02973685CI-TRIAL-00067088completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with large hepatocellular carcinoma staged BCLC A/B.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HepatoCellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Folfox Protocol | Drug | — | UNRESOLVED |
| Hepatic arterial infusion chemotherapy | Procedure | — | UNRESOLVED |
| TACE Drug Protocol | Drug | — | UNRESOLVED |
| Transarterial chemoembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hepatic arterial infusion chemotherapy
- description
- Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: Folfox Protocol. Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
- interventionNames
- Procedure: Hepatic arterial infusion chemotherapy
- Drug: Folfox Protocol
- type
- ACTIVE_COMPARATOR
- label
- Transarterial chemoembolization
- description
- Procedure/Surgery: Transarterial chemoembolization Drug: TACE Drug Protocol. Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, with or without MMC), and embolization with polyvinyl alcohol particles (PVA).
- interventionNames
- Procedure: Transarterial chemoembolization
- Drug: TACE Drug Protocol
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age range from 18-75 years; * KPS≥70; * The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL), simultaneously staged as BCLC A or BCLC B based on Barcelona Clinic Liver Cancer staging system. * Patients must have at least one tumor lesion that can be accurately measured; * The sum of diameters of all lesions longer than 10 cm with the maximum lesion longer than 7 cm. * Diagnosed as unresectable with consensus by the panel of liver surgery experts; * Re commanded treated by TAI or TACE with consensus by the panel of liver MDT; * No past history of TACE, TAI, chemotherapy or molecule-targeted treatment; * No Cirrhosis or cirrhotic status of Child-Pugh class A only * Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL;(b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin ≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine ≤ 1.5 x upper limit of normal;(g) INR \> 2.3 or PT/APTT within normal limits;(h) Absolute neutrophil count (ANC) \>1,500/mm3; * Ability to understand the protocol and to agree to and sign a written informed consent document. Exclusion Criteria: * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * Known history of HIV * History of organ allograft * Known or suspected allergy to the investigational agents or any agent given in association with this trial. * Evidence of bleeding diathesis. * Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug * Serious non-healing wound, ulcer, or bone fracture * Known central nervous system tumors including metastatic brain disease * Poor compliance that can not comply with the course of treatment and follow up.
References
Publications (2)
- DERIVEDHan X, Peng C, Ruan SM, Li L, He M, Shi M, Huang B, Luo Y, Liu J, Wen H, Wang W, Zhou J, Lu M, Chen X, Zou R, Liu Z. A Contrast-Enhanced Ultrasound Cine-Based Deep Learning Model for Predicting the Response of Advanced Hepatocellular Carcinoma to Hepatic Arterial Infusion Chemotherapy Combined With Systemic Therapies. Cancer Sci. 2025 Jul;116(7):1930-1940. doi: 10.1111/cas.70089. Epub 2025 Apr 29. PMID 40302359
- DERIVEDLi QJ, He MK, Chen HW, Fang WQ, Zhou YM, Xu L, Wei W, Zhang YJ, Guo Y, Guo RP, Chen MS, Shi M. Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Versus Transarterial Chemoembolization for Large Hepatocellular Carcinoma: A Randomized Phase III Trial. J Clin Oncol. 2022 Jan 10;40(2):150-160. doi: 10.1200/JCO.21.00608. Epub 2021 Oct 14. PMID 34648352