TACE-HAIC vs. HAIC for Potentially Resectable HCC

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma; Potentially Resection
• Interventions: Drug: TACE-HAIC; Drug: HAIC

• Registration Number: NCT03591705
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-06
• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-19
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-22
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACE-HAIC	TACE-HAIC	hepatic artery chemo-lipiodolization with EADM, followed by FOLFOX-based chemotherapy artery infusion
HAIC	HAIC	FOLFOX-based chemotherapy hepatic artery infusion

Primary Outcome Measures

Name	Time	Method
progression-free survival	6-12 months	Time to progression, last follow-up or death after random assignment to TACE-HAIC or HAIC

Secondary Outcome Measures

Name	Time	Method
overall survival	6-12 months	time to death or last follow-up after random assignment to TACE-HAIC or HAIC
Downstage hepatectomy rate	6-12 months	The hepatectomy rate after TACE-HAIC or HAIC

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China