ClinicalTrials.Veeva

Menu

Sorafenib Alone Versus Sorafenib Combined With HAIC for Advanced HCC

Sun Yat-sen University logo

Sun Yat-sen University

Status and phase

Completed
Phase 3

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Sorafenib
Drug: Folfox Protocol
Procedure: Hepatic arterial infusion chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02774187
HCC-S021

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) compared with sorafenib Alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).

Full description

The results of our preliminary pilot study suggested that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for advanced stage HCC. Thus, the investigators carried out this prospective randomized control study to find out it.

Enrollment

247 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The diagnosis of 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.

  • portal vein tumor thrumbus confirmed in two image techniques

  • Eastern Cooperative Oncology Group performance status of 0 to 2

  • 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

  • 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.
  • Known central nervous system tumors including metastatic brain disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

247 participants in 2 patient groups

Sorafenib combined with HAIC
Experimental group
Description:
Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol
Treatment:
Procedure: Hepatic arterial infusion chemotherapy
Drug: Folfox Protocol
Drug: Sorafenib
Sorafenib alone
Active Comparator group
Description:
Sorafenib alone
Treatment:
Drug: Sorafenib

Trial contacts and locations

5

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems