HAIC Versus TACE for Large and Unresectable Hepatocellular Carcinoma Staged BCLC A/B

NCT ID: NCT03048123

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2017-01-24

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with large and unresectable hepatocellular carcinoma staged BCLC A/B.

Detailed Description

Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma staged BCLC A/B. Our previous prospective study also revealed similar results of large HCC patients treated with TACE. Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve tumor response for HCC with large HCC.

Thus, the investigators carried out this prospective nonrandomized control to demonstrate the superiority of HAIC over TACE.

Conditions

Hepatocellular Carcinoma

Study Design

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

Study Groups

Hepatic arterial infusion chemotherapy

Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: Folfox Protocol. Hepatic intraarterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin

Group Type: EXPERIMENTAL

Hepatic arterial infusion

Intervention Type: PROCEDURE

A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. In the event of multiple arterial supply(including superior-mesenteric artery), the proportion of the liver supplied by each artery was estimated by the arteriogram. After optimal positioning of the catheter in dominant supplying artery to ensure minimal reflux, the catheter was fixed and connected with infusion tube. In the condition of multiple tumors on both left and right lobe, the gastroduodenal artery was embolized and the catheter was positioned in the hepatic proper artery for infusion. Folfox Protocol were infused through the fixed catheter sequentially

Folfox Protocol

Intervention Type: DRUG

oxaliplatin,leucovorin and 5-FU

Transarterial chemoembolization

Procedure/Surgery: Transarterial chemoembolization Drug: TACE Drug Protocol. Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA)

Group Type: ACTIVE_COMPARATOR

Transarterial chemoembolization

Intervention Type: PROCEDURE

Previous procedure was same with hepatic arterial infusion chemotherapy. After optimal positioning of the catheter, TACE Drug Protocol were injected.

TACE Drug Protocol

Intervention Type: DRUG

lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, and MMC) followed by polyvinyl alcohol particles (PVA)

Interventions

Hepatic arterial infusion

A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. In the event of multiple arterial supply(including superior-mesenteric artery), the proportion of the liver supplied by each artery was estimated by the arteriogram. After optimal positioning of the catheter in dominant supplying artery to ensure minimal reflux, the catheter was fixed and connected with infusion tube. In the condition of multiple tumors on both left and right lobe, the gastroduodenal artery was embolized and the catheter was positioned in the hepatic proper artery for infusion. Folfox Protocol were infused through the fixed catheter sequentially

Intervention Type: PROCEDURE

Transarterial chemoembolization

Previous procedure was same with hepatic arterial infusion chemotherapy. After optimal positioning of the catheter, TACE Drug Protocol were injected.

Intervention Type: PROCEDURE

Folfox Protocol

oxaliplatin,leucovorin and 5-FU

Intervention Type: DRUG

TACE Drug Protocol

lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, and MMC) followed by polyvinyl alcohol particles (PVA)

Intervention Type: DRUG

Other Intervention Names

Folfox for TAI; Drugs for transarterial chemotherapy and embolization

Eligibility Criteria

Inclusion Criteria

• Age range from 18-75 years;
• KPS≥70;
• The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL), simultaneously staged as BCLC A or BCLC B based on Barcelona Clinic Liver Cancer staging system.
• Patients must have at least one tumor lesion that can be accurately measured;
• Solitary tumor with diameter ≥10cm, invaded both left and right lobe; or multiple tumors, diameter of the largest was more than 7cm.
• Diagnosed as unresectable with consensus by the panel of liver surgery experts;
• Re commanded treated by TAI or TACE with consensus by the panel of liver MDT;
• No past history of TACE, TAI, chemotherapy or molecule-targeted treatment;
• No Cirrhosis or cirrhotic status of Child-Pugh class A only
• No liver protection therapy in 2 weeks before enrolled, and meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin

≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine

≤ 1.5 x upper limit of normal;(g) INR > 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) >1,500/mm3;

• Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria

• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• Known history of HIV
• History of organ allograft
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Evidence of bleeding diathesis.
• Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
• Serious non-healing wound, ulcer, or bone fracture
• Known central nervous system tumors including metastatic brain disease
• Poor compliance that can not comply with the course of treatment and follow up.

• 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

Shi Ming

Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Shi, MD

Role: PRINCIPAL_INVESTIGATOR

The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center

Locations

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

HCC-170206

Identifier Type: -

Identifier Source: org_study_id