TACE-HAIC vs. HAIC for Potentially Resectable HCC

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03591705

Collaborator

(none)

240

Enrollment

Location

Arms

77.8

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Potentially Resection Hepatocellular Carcinoma	Drug: TACE-HAIC Drug: HAIC	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 6, 2018

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TACE-HAIC hepatic artery chemo-lipiodolization with EADM, followed by FOLFOX-based chemotherapy artery infusion	Drug: TACE-HAIC 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.
Active Comparator: HAIC FOLFOX-based chemotherapy hepatic artery infusion	Drug: HAIC hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2 infusion 23h.

Arm

Intervention/Treatment

Experimental: TACE-HAIC

hepatic artery chemo-lipiodolization with EADM, followed by FOLFOX-based chemotherapy artery infusion

Drug: TACE-HAIC

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.

Active Comparator: HAIC

FOLFOX-based chemotherapy hepatic artery infusion

Drug: HAIC

hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2 infusion 23h.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator: Yunfei Yuan, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yunfei Yuan, Professor, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT03591705

Other Study ID Numbers:

B2018-044

First Posted:

Jul 19, 2018

Last Update Posted:

Sep 22, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Sep 22, 2021