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

Phase 3

Completed

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

• Registration Number: NCT02973685
• 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 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 especially for those with tumor larger than 10 cm. 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 the survivals for HCC with large HCC. Thus, the investigators carried out this prospective randomized control to demonstrate the superiority of HAIC over TACE.

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2016-11-20
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-25
• Primary Completion: 2020-11-28
• Study Completion: 2020-11-28
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

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;
• The sum of diameters of all lesions longer than 10 cm with the maximum lesion longer than 7 cm.
• 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
• 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
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, with or without MMC), and embolization with polyvinyl alcohol particles (PVA).
Transarterial chemoembolization	Transarterial chemoembolization	Procedure/Surgery: Transarterial chemoembolization Drug: TACE Drug Protocol. Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, with or without MMC), and embolization with polyvinyl alcohol particles (PVA).
Hepatic arterial infusion chemotherapy	Hepatic arterial infusion chemotherapy	Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: Folfox Protocol. Hepatic intra-arterial 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 intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin

Primary Outcome Measures

Name	Time	Method
Overall survival	24 months

Secondary Outcome Measures

Name	Time	Method
Number of of Patients developed Adverse Events	30 Days after HAIC	Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v3.0
Time to progression	24 months
Adverse Events	30 Days after HAIC	Postoperative adverse events were graded based on CTCAE v4.03

Trial Locations

Locations (3)

The First People's Hospital of Foshan; 🇨🇳 Foshan, Guangdong, China

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

Guangzhou Twelfth People's Hospital; 🇨🇳 Guangzhou, Guangdong, China