TACE-HAIC vs. HAIC for Potentially Resectable HCC

Sun Yat-sen University

Status: Enrolling

Conditions: Potentially Resection; Hepatocellular Carcinoma

Treatments: Drug: HAIC; Drug: TACE-HAIC

Study type: Interventional

Funder types: Other

Identifiers

NCT03591705

B2018-044

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

TACE-HAIC

Experimental group

Description:

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

Treatment:

Drug: TACE-HAIC

HAIC

Active Comparator group

Description:

FOLFOX-based chemotherapy hepatic artery infusion

Treatment:

Drug: HAIC