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

Hepatocellular Carcinoma Clinical Trial

Official title:

The Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Compared With Transarterial Chemoembolization in Patients With Large and Unresectable Hepatocellular Carcinoma Staged BCLC A/B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03048123
• Other study ID #: HCC-170206
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2017
• Last updated: February 7, 2017
• Start date: October 1, 2015
• Est. completion date: January 24, 2017

Study information

• Verified date: February 2017
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: January 24, 2017
• Est. primary completion date: October 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Drug:
• Folfox Protocol
oxaliplatin,leucovorin and 5-FU
• TACE Drug Protocol
lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, and MMC) followed by polyvinyl alcohol particles (PVA)

Locations

Country	Name	City	State
China	Cancer Center Sun Yat-sen University	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	Disease control rate	Best response based on RECIST	16 months
Secondary	Time to progression		16 months
Secondary	Adverse Events	Postoperative adverse events were graded based on CTCAE v4.03	30 Days after HAIC and TACE