HAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC

Phase 3

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Hepatic arterial infusion chemotherapy; Procedure: Transarterial chemoembolization; Drug: HAIC Regimen; Drug: TACE regimen; Drug: Oral Sorafenib

• Registration Number: NCT02856126
• 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 BCLC stage hepatocellular carcinoma (HCC).

Detailed 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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-04
• Primary Completion: 2020-10
• Status Verified: 2024-07
• Study Completion: 2024-07
• Last Update Submitted: 2024-07-20
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HAIC plus sorafenib	Hepatic arterial infusion chemotherapy	Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: HAIC Regimen Drug: Oral Sorafenib
HAIC plus sorafenib	HAIC Regimen	Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: HAIC Regimen Drug: Oral Sorafenib
TACE plus sorafenib	TACE regimen	Procedure/Surgery: Transarterial chemoembolization Drug: TACE regimen Drug: Oral Sorafenib
TACE plus sorafenib	Transarterial chemoembolization	Procedure/Surgery: Transarterial chemoembolization Drug: TACE regimen Drug: Oral Sorafenib
TACE plus sorafenib	Oral Sorafenib	Procedure/Surgery: Transarterial chemoembolization Drug: TACE regimen Drug: Oral Sorafenib
HAIC plus sorafenib	Oral Sorafenib	Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: HAIC Regimen Drug: Oral Sorafenib

Primary Outcome Measures

Name	Time	Method
Overall survival	18 months	Overall survival

Secondary Outcome Measures

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

Trial Locations

Locations (7)

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of University Of South China; 🇨🇳 Hengyang, Hunan, China

Dongguan People's Hospital; 🇨🇳 Dongguan, Guangdong, China

Kaiping Central Hospital; 🇨🇳 Kaiping, Guangdong, China

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

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

The First Affiliated Hospital Of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shanxi, China