Sorafenib Alone Versus Sorafenib Combined With HAIC for Advanced HCC

NCT02774187 | Completed Phase 3 DMC

• 1 other identifier: HCC-S021
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Hepatic arterial infusion chemotherapy; Sorafenib

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival

  6 months

Secondary Outcomes (3)

• Time to progression

  6 months

• Adverse Events

  30 days

• Number of of Patients developed Adverse Events

  30 days

Study Arms (2)

Sorafenib combined with HAIC

EXPERIMENTAL

Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol

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

Sorafenib alone

ACTIVE COMPARATOR

Sorafenib alone

Drug: Sorafenib

Interventions

Sorafenib DRUG

administration of Sorafenib

Sorafenib alone; Sorafenib combined with HAIC

Hepatic arterial infusion chemotherapy PROCEDURE

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

Also known as: HAIC

Sorafenib combined with HAIC

Folfox Protocol DRUG

Oxaliplatin , fluorouracil, and leucovorin

Also known as: Oxaliplatin , fluorouracil, and leucovorin

Sorafenib combined with HAIC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Kaiping Central Hospital: collaborator
• Guangzhou No.12 People's Hospital: collaborator
• The First Affiliated Hospital of University of South China: collaborator

Study Sites (5)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Guangzhou Twelfth People 's Hospita

Guangzhou, Guangdong, 510620, China

Location

The Kaiping Center's Hospital

Kaiping, Guangdong, 529300, China

Location

First Affiliated Hospital of University Of South China

Hengyang, Hunan, 421001, China

Location

Related Publications (9)

• 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.

  PMID: 12049862 RESULT

• 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.

  PMID: 11981766 RESULT

• 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.

  PMID: 12540794 RESULT

• 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.

  PMID: 20839057 RESULT

• 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.

  PMID: 9149014 RESULT

• 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.

  PMID: 20686792 RESULT

• 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.

  PMID: 21514523 RESULT

• 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.

  PMID: 25742141 RESULT

• 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.

  PMID: 31070690 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib; Folfox protocol; Oxaliplatin; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Uracil; Pyrimidinones; Pyrimidines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Ming Shi, MD

  The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 17, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2018
• Last Updated: December 5, 2019

Record last verified: 2019-12

Locations

CN (5)