HAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

The Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Plus Sorafenib Compared With Transarterial Chemoembolization Plus Sorafenib in Patients With BCLC C Stage Hepatocellular Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02856126
• Other study ID #: HCC-S022
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 2016
• Est. completion date: June 2022

Study information

• Verified date: June 2022
• 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 BCLC stage hepatocellular carcinoma (HCC).

Description:

Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. Our previous prospective study also revealed that TACE confers a survival benefit to patients with HCC and portal venous tumor thrombus (PVTT). Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for patitens with BCLC stage C HCC. Thus, the investigators carried out this prospective randomized control study to find out it.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 214
• Est. completion date: June 2022
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The diagnosis of BCLC C stage HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)

• Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.

• with no previous treatment

• No Cirrhosis or cirrhotic status of Child-Pugh class A only

• Not amendable to surgical resection ,local ablative therapy and any other cured treatment.

• The following laboratory parameters:

• Platelet count = 75,000/µL

• Hemoglobin = 8.5 g/dL

• Total bilirubin = 30mmol/L

• Serum albumin = 30 g/L

• ASL and AST = 5 x upper limit of normal

• Serum creatinine = 1.5 x upper limit of normal

• INR = 1.5 or PT/APTT within normal limits

• 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:

• Main portal vein occlusion

• 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.

• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

• Evidence of bleeding diathesis.

• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Hepatic arterial infusion chemotherapy

• Transarterial chemoembolization

Drug:
• TACE regimen
infusion with lipiodol mixed with chemotherapy drugs (EADM , lobaplatin, and MMC ), and embolization with polyvinyl alcohol particles (PVA)
• HAIC Regimen
Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
• Oral Sorafenib
Oral Sorafenib, 400mg, Bid

Locations

Country	Name	City	State
China	Dongguan People's Hospital	Dongguan	Guangdong
China	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong
China	Guangzhou Twelfth People 's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of University Of South China	Hengyang	Hunan
China	Kaiping Central Hospital	Kaiping	Guangdong
China	The First Affiliated Hospital Of Xi'an Jiaotong University	Xi'an	Shanxi

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	Overall survival	Overall survival	18 months
Secondary	Progress free survival	Progress free survival	18 months
Secondary	Adverse Events	Number of adverse events. Postoperative adverse events were graded based on CTCAE v3.0	30 Days
Secondary	Number of of Patients developed Adverse Events	Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v3.0	30 Days