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CompletedNCT02774187Updated Dec 5, 2019

Sorafenib Alone Versus Sorafenib Combined With HAIC for Advanced HCC

A Phase 3 interventional study of Sorafenib and Hepatic arterial infusion chemotherapy in Hepatocellular Carcinoma, sponsored by Sun Yat-sen University. Completed at 5 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-05.

Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
247
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

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).

Read the detailed 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.

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Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Hepatocellular Carcinoma
  • Hepatic arterial infusion chemotherapy
  • Sorafenib
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In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's enrollment of 247 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
247 participants (actual)

Study arms

  • Experimental
    Sorafenib combined with HAIC

    Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol

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

  • Active comparator
    Sorafenib alone

    Sorafenib alone

    Drug: Sorafenib

Interventions

  • DrugSorafenib

    administration of Sorafenib

  • ProcedureHepatic arterial infusion chemotherapy

    administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

    Also known as: HAIC

  • DrugFolfox Protocol

    Oxaliplatin , fluorouracil, and leucovorin

    Also known as: Oxaliplatin , fluorouracil, and leucovorin

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What researchers measure

Primary outcomes

  1. Overall survival

    Overall survival

    Time frame: 6 months

Secondary outcomes

  1. Time to progression

    Time to progression

    Time frame: 6 months

  2. Adverse Events

    Number of adverse events. Postoperative adverse events were graded based on CTCAE v3.0

    Time frame: 30 days

  3. 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

    Time frame: 30 days

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Study locations

5 sites
  • Cancer Center Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
  • The First Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
  • Guangzhou Twelfth People 's Hospita
    Guangzhou, Guangdong 510620, China
  • The Kaiping Center's Hospital
    Kaiping, Guangdong 529300, China
  • First Affiliated Hospital of University Of South China
    Hengyang, Hunan 421001, China
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References and documents

Publications

  • Llovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X. PubMed 12049862 ↗
  • Lo CM, Ngan H, Tso WK, Liu CL, Lam CM, Poon RT, Fan ST, Wong J. Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma. Hepatology. 2002 May;35(5):1164-71. doi: 10.1053/jhep.2002.33156. PubMed 11981766 ↗
  • Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047. PubMed 12540794 ↗
  • Luo J, Guo RP, Lai EC, Zhang YJ, Lau WY, Chen MS, Shi M. Transarterial chemoembolization for unresectable hepatocellular carcinoma with portal vein tumor thrombosis: a prospective comparative study. Ann Surg Oncol. 2011 Feb;18(2):413-20. doi: 10.1245/s10434-010-1321-8. Epub 2010 Sep 14. PubMed 20839057 ↗
  • Ando E, Yamashita F, Tanaka M, Tanikawa K. A novel chemotherapy for advanced hepatocellular carcinoma with tumor thrombosis of the main trunk of the portal vein. Cancer. 1997 May 15;79(10):1890-6. doi: 10.1002/(sici)1097-0142(19970515)79:103.0.co;2-k. PubMed 9149014 ↗
  • Shi J, Lai EC, Li N, Guo WX, Xue J, Lau WY, Wu MC, Cheng SQ. A new classification for hepatocellular carcinoma with portal vein tumor thrombus. J Hepatobiliary Pancreat Sci. 2011 Jan;18(1):74-80. doi: 10.1007/s00534-010-0314-0. PubMed 20686792 ↗
  • Huang ZL, Luo J, Chen MS, Li JQ, Shi M. Blood neutrophil-to-lymphocyte ratio predicts survival in patients with unresectable hepatocellular carcinoma undergoing transarterial chemoembolization. J Vasc Interv Radiol. 2011 May;22(5):702-9. doi: 10.1016/j.jvir.2010.12.041. PubMed 21514523 ↗
  • Fan W, Zhang Y, Wang Y, Yao X, Yang J, Li J. Neutrophil-to-lymphocyte and platelet-to-lymphocyte ratios as predictors of survival and metastasis for recurrent hepatocellular carcinoma after transarterial chemoembolization. PLoS One. 2015 Mar 5;10(3):e0119312. doi: 10.1371/journal.pone.0119312. eCollection 2015. PubMed 25742141 ↗
  • He M, Li Q, Zou R, Shen J, Fang W, Tan G, Zhou Y, Wu X, Xu L, Wei W, Le Y, Zhou Z, Zhao M, Guo Y, Guo R, Chen M, Shi M. Sorafenib Plus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib Alone for Hepatocellular Carcinoma With Portal Vein Invasion: A Randomized Clinical Trial. JAMA Oncol. 2019 Jul 1;5(7):953-960. doi: 10.1001/jamaoncol.2019.0250. PubMed 31070690 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02774187
Lead sponsor
Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Kaiping Central Hospital, Guangzhou No.12 People's Hospital, The First Affiliated Hospital of University of South China
Responsible party
Shi Ming (professor, Sun Yat-sen University) — Principal investigator
First posted
May 17, 2016
Start date
May 2016
Primary completion
Jul 2017
Completion
Aug 2018
Last update
Dec 5, 2019

Study contacts

Ming Shi, MD
principal investigator · The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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