HAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: HAIC Regimen; Drug: TACE regimen; Procedure: Transarterial chemoembolization; Drug: Oral Sorafenib; Procedure: Hepatic arterial infusion chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02856126

HCC-S022

Details and patient eligibility

About

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).

Full 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.

Enrollment: 214 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

HAIC plus sorafenib

Experimental group

Description:

Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: HAIC Regimen Drug: Oral Sorafenib

Treatment:

Procedure: Hepatic arterial infusion chemotherapy

Drug: Oral Sorafenib

Drug: HAIC Regimen

TACE plus sorafenib

Active Comparator group

Description:

Procedure/Surgery: Transarterial chemoembolization Drug: TACE regimen Drug: Oral Sorafenib

Treatment:

Drug: Oral Sorafenib

Drug: TACE regimen

Procedure: Transarterial chemoembolization