TACE-HAIC vs. HAIC for Potentially Resectable HCC

NCT ID: NCT03591705

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-06
• Study Completion Date: 2024-12-30

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.

Conditions

Potentially Resection; Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TACE-HAIC

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

Group Type: EXPERIMENTAL

TACE-HAIC

Intervention Type: DRUG

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

FOLFOX-based chemotherapy hepatic artery infusion

Group Type: ACTIVE_COMPARATOR

HAIC

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

HAIC

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yunfei Yuan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yunfei Yuan

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiliang Qiu

Role: CONTACT

qiujl@sysucc.org.cn

+862087342654

Facility Contacts

Yunfei Yuan

Role: primary

yuanyf@mail.sysu.edu.cn

+862087343118

Other Identifiers

B2018-044

Identifier Type: -

Identifier Source: org_study_id