TACE-HAIC vs. HAIC for Potentially Resectable HCC

Study Overview
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Brief Summary
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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.

Official Title
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Transarterial Chemoembolization Versus Transarterial Chemoembolization With Hepatic Artery Chemotherapy Infusion for Patients With Potentially Resectable HCC

Conditions
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Potentially Resection, Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: TACE-HAIC
* Drug: HAIC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) Diagnosed as potentially resectable with consensus by the panel of liver surgeons stage BCLC A/B, without extra-hepatic involvement No previous anti-HCC treatment Eastern Co-operative Group performance status 2 or less Liver function: Child's A or B (score < 7) Exclusion Criteria: Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy underlying serve cardiac or renal diseases Known or suspected allergy to the investigational agent or any agent given in association with this trial Patients ineligible for hepatic artery embolization

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TACE-HAIC<br>hepatic artery chemo-lipiodolization with EADM, followed by FOLFOX-based chemotherapy artery infusion | Drug: TACE-HAIC<br>* transcatheter arterial chemo-lipiodolization with EADM 30mg/m2, followed by hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2 infusion 23h.<br>|
| Active Comparator: HAIC<br>FOLFOX-based chemotherapy hepatic artery infusion | Drug: HAIC<br>* hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2 infusion 23h.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | Time to progression, last follow-up or death after random assignment to TACE-HAIC or HAIC | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | time to death or last follow-up after random assignment to TACE-HAIC or HAIC | 6-12 months | 
| Downstage hepatectomy rate | The hepatectomy rate after TACE-HAIC or HAIC | 6-12 months |