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

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Hepatic arterial infusion; Procedure: Transarterial chemoembolization; Drug: Folfox Protocol; Drug: TACE Drug Protocol

• Registration Number: NCT03048123
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2015-10-01
• Primary Completion: 2016-10-01
• Study Completion: 2017-01-24
• Status Verified: 2017-02
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-07
• Last Update Submitted: 2017-02-07
• Study First Posted: 2017-02-09
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hepatic arterial infusion chemotherapy	Hepatic arterial infusion	Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: Folfox Protocol. Hepatic intraarterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
Hepatic arterial infusion chemotherapy	Folfox Protocol	Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: Folfox Protocol. Hepatic intraarterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
Transarterial chemoembolization	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)
Transarterial chemoembolization	TACE Drug Protocol	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)

Primary Outcome Measures

Name	Time	Method
Disease control rate	16 months	Best response based on RECIST

Secondary Outcome Measures

Name	Time	Method
Time to progression	16 months
Adverse Events	30 Days after HAIC and TACE	Postoperative adverse events were graded based on CTCAE v4.03

Trial Locations

Locations (1)

Cancer Center Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China