TACE With or Without Sorafenib in Intermediate Stage Hepatocellular Carcinoma

NCT02529761 | Unknown

• 1 other identifier: S-T 002
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter prospective nonrandomized study is to evaluate the efficacy of TACE combined with sorafenib compared with TACE monotherapy in term of overall survival in intermediate-stage HCC.

Conditions

Hepatocellular Carcinoma

Keywords

HCC; sorafenib; TACE; overall survival

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival analysis is measured from the treatment start until death occurred from any cause

  The last patient has been on study for 1.5 year

Secondary Outcomes (4)

• Time to progression

  The time to progression will be assessed at the end of the study, up to 3 years

• Tumor response

  Tumor response will be assessed at week 4 and week 8 after initiation of treatment and thereafter every 8 weeks (±7 days), up to 3 years

• Adverse events

  The adverse events will be assessed every 4 weeks, up to 3 years

• Prognostic factor

  The analysis will be perfomed when the last patient has been on study for 1.5 year

Study Arms (2)

Sorafenib combined with TACE

EXPERIMENTAL

220 subjects in this study group will receive the treatment of sorafenib combined with conventional TACE.

Drug: Sorafenib; Procedure: TACE

TACE monotherapy

ACTIVE COMPARATOR

110 subjects in this study group will receive the treatment of conventional TACE monotherapy.

Procedure: TACE

Interventions

Sorafenib DRUG

Sorafenib will be supplied as 200 mg tablets. All subjects will take two tablets of sorafenib (200 mg tablets) twice daily (each morning and evening).

Also known as: •Bay 43-9006, Sorafenib (Nexavar®)

Sorafenib combined with TACE

TACE PROCEDURE

The first treatment of TACE should be completed within 3-7 days after the administration of sorafenib started. In all cases, TACE consists of an injection containing a mixture of chemotherapeutic agents and lipiodol followed by embolization with polyvinyl alcohol (PVA) particles until complete stasis was achieved in the tumor-feeding vessels.Tumor-feeding vessels should be selected/superselected whenever possible. TACE will be repeated "on demand" depending on the radiological response.

Also known as: conventional transarterial chemeombolization

Sorafenib combined with TACE; TACE monotherapy

Eligibility Criteria

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

You may qualify if:

• Prior informed consent
• Intermediate stage HCC/ BCLC B stage
• Confirmed Diagnosis of HCC:
• Cirrhotic subjects: Clinical diagnosis by AASLD criteria. HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter. Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.
• Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory. Documentation of original biopsy for diagnosis is acceptable
• Child Pugh class A/B(7) class without ascites or hepatic encephalopathy
• ECOG Performance Status of 0-1
• At least one uni-dimensional lesion measurable by CT-scan or MRI according to the RECIST 1.1, mRECIST and EASL criteria, respectively.
• Single lesion\>5cm
• lesions, at least one lesion\>3cm; if more than 4 lesions, no limitation of the tumor size, but the sum of size of all tumor lesions should be less than 50% of liver parenchyma.
• Male or female subject ≥ 18 years of age
• Ability to swallow oral medications
• Life expectancy of at least 12 weeks
• Pregnancy test negative within 14 days before treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial
• Adequate bone marrow, liver and renal functions as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:

You may not qualify if:

• Diffuse HCC or tumor size ≥50% of liver parenchyma
• Vascular invasion
• Presence of extrahepatic metastasis
• Poor blood supply for the liver tumor lesions; poor blood supply refers that the tumor lesions fail to show obvious contrast uptake in the arterial phase and washout in venous or late phases by CT scan or MRI
• Any contraindications for hepatic embolization procedures:
• Known hepatofugal blood flow
• Known porto-systemic shunt
• Renal failure / insufficiency requiring hemo-or peritoneal dialysis
• Target lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI)
• Investigational drugs or other molecular target drugs ongoing or completed \< 4 weeks prior to the baseline scan
• Prior transarterial embolization or anti-tumor systemic chemotherapy
• Any ≥ CTC AE grade 2 acute toxic effects of any prior local treatment
• Patients with untreated varices or active bleeding
• History of cardiac disease:
• Congestive heart failure \>New York Heart Association (NYHA) class 2

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing Hospital of digestive disease, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (2)

• European Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012 Apr;56(4):908-43. doi: 10.1016/j.jhep.2011.12.001. No abstract available.

  PMID: 22424438 RESULT

• Zhao Y, Wang WJ, Guan S, Li HL, Xu RC, Wu JB, Liu JS, Li HP, Bai W, Yin ZX, Fan DM, Zhang ZL, Han GH. Sorafenib combined with transarterial chemoembolization for the treatment of advanced hepatocellular carcinoma: a large-scale multicenter study of 222 patients. Ann Oncol. 2013 Jul;24(7):1786-1792. doi: 10.1093/annonc/mdt072. Epub 2013 Mar 18.

  PMID: 23508822 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

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

Study Officials

• Guohong Han, MD

  Xijing Hospital of Digestive Disease, Fourth Military Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guohong Han, MD

CONTACT

+862984771528; guohhan@126.com

Wei Bai, MD

CONTACT

chris41532@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 20, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 1, 2019

Record last verified: 2019-08

Locations

CN (1)