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.
1 other identifier
interventional
315
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hepatocellular-carcinoma
Started Oct 2016
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 20, 2016
CompletedFirst Posted
Study publicly available on registry
November 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2020
CompletedJune 12, 2023
June 1, 2023
4.2 years
November 20, 2016
June 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
24 months
Secondary Outcomes (3)
Time to progression
24 months
Adverse Events
30 Days after HAIC
Number of of Patients developed Adverse Events
30 Days after HAIC
Study Arms (2)
Hepatic arterial infusion chemotherapy
EXPERIMENTALProcedure/Surgery: Hepatic arterial infusion chemotherapy Drug: Folfox Protocol. Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
Transarterial chemoembolization
ACTIVE COMPARATORProcedure/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).
Interventions
A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. In the event of multiple arterial supply(including superior-mesenteric artery), the proportion of the liver supplied by each artery was estimated by the arteriogram. After optimal positioning of the catheter in dominant supplying artery to ensure minimal reflux, the catheter was fixed and connected with infusion tube. In the condition of multiple tumors on both left and right lobe, the gastroduodenal artery was embolized and the catheter was positioned in the hepatic proper artery for infusion. Folfox Protocol were infused through the fixed catheter sequentially.
Previous procedure was same with hepatic arterial infusion chemotherapy. After optimal positioning of the catheter, TACE Drug Protocol were injected.
oxaliplatin,leucovorin and 5-FU
lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, with or without MMC) followed by polyvinyl alcohol particles (PVA)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- Guangzhou No.12 People's Hospitalcollaborator
- First People's Hospital of Foshancollaborator
Study Sites (3)
The First People's Hospital of Foshan
Foshan, Guangdong, 510060, China
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
Guangzhou Twelfth People's Hospital
Guangzhou, Guangdong, 510620, China
Related Publications (2)
Han 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: 40302359DERIVEDLi 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: 34648352DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ming Shi, MD
The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Proffessor
Study Record Dates
First Submitted
November 20, 2016
First Posted
November 25, 2016
Study Start
October 1, 2016
Primary Completion
November 28, 2020
Study Completion
November 28, 2020
Last Updated
June 12, 2023
Record last verified: 2023-06