TACE-HAIC vs. HAIC for Potentially Resectable HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03591705
• Other study ID #: B2018-044
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2018
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2021
• Source: Sun Yat-sen University
• Contact: Jiliang Qiu
• Phone: +862087342654
• Email: qiujl[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Potentially Resection

Intervention

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

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	Time to progression, last follow-up or death after random assignment to TACE-HAIC or HAIC	6-12 months
Secondary	overall survival	time to death or last follow-up after random assignment to TACE-HAIC or HAIC	6-12 months
Secondary	Downstage hepatectomy rate	The hepatectomy rate after TACE-HAIC or HAIC	6-12 months