Sorafenib Chemoembolization Evaluation Controlled Trial

NCT01906216 | Completed Phase 3

• 1 other identifier: XHDD-001
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, multicenter, randomized, controlled study aims to evaluate the efficacy and safety of sorafenib combined with transarterial chemoembolization (TACE) in advanced hepatocellular carcinoma (HCC) patients compared with sorafenib alone, and to determine the prognostic factors that influence the survival. Data on the efficacy and safety of sorafenib in combination with TACE in patients with advanced HCC are lacking. Because in western countries, advanced HCC is considered as a contraindication for TACE treatment. However, clinical practice patterns differ markedly between Asia and western countries: in Asia TACE is performed in selected advanced HCC patients. We consider sorafenib combined with TACE could achieve better survival benefit than sorafenib alone in selected advanced HCC patients.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; sorafenib; transarterial chemoembolization

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival (OS) analysis is measured from the time of randomization until death occurred from any cause.

  The final analysis will occur when the expected number of death (173 events) is reached. Up to 2.5 years

Secondary Outcomes (3)

• Time to progression

  The time to progression will be assessed at the end of the study, up to 2.5 years

• Tumor response

  Tumor response will be assessed up to 2.5 years

• Adverse events

  The adverse events will be assessed up to 2.5 years.

Other Outcomes (1)

• AFP response

  The AFP response will be assessed up to 2.5 years.

Study Arms (2)

Sorafenib

ACTIVE COMPARATOR

All subjects will take two tablets of sorafenib (200 mg tablets) twice daily (each morning and evening). Sorafenib may be taken either with a low/moderate fat meal or without food. Subjects are to continue sorafenib according to the study protocol if the adverse events could be safely controlled.

Drug: Sorafenib

Sorafenib combined with TACE

EXPERIMENTAL

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). In addition, the subjects in this arm will receive the treatment of conventional transarterial chemoembolization. In all cases, TACE consists of an injection containing a mixture of chemotherapeutic agents(doxorubicin) and lipiodol followed by embolization with polyvinyl alcohol (PVA) or beads.

Drug: Sorafenib; 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; 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) or beads 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.

Sorafenib combined with TACE

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
• Advanced stage HCC/ Barcelona Clinic Liver Cancer(BCLC) C stage
• Confirmed Diagnosis of HCC:
• Cirrhotic subjects: Clinical diagnosis by Asian Pacific Association for the Study of the Liver(AASLD) 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 without ascites or hepatic encephalopathy
• Eastern Cooperative Oncology Group(ECOG) Performance Status of 0-1
• At least one uni-dimensional lesion measurable by CT-scan or MRI according to the RECIST, 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 subjects ≥ 18 years of age
• Ability to swallow oral medications
• Life expectancy of at least 12 weeks
• 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

You may not qualify if:

• Diffuse HCC or tumor burden ≥50% of liver parenchyma
• Main portal vein obstruction, vascular invasion in hepatic vein or inferior vena cava
• Presence of metastasis in biliary tract,brain or bone
• 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)
• Other molecular target drugs ongoing or completed \< 4 weeks prior to the baseline scan
• Prior transarterial embolization or systemic chemotherapy
• Any ≥ CTC adverse events(AEs) 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

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• 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 BACKGROUND

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，PhD

  Xijing Hospital of Digestive Disease, Fourth Military Medical University

  STUDY CHAIR

• Guohong Han, MD，PhD

  Department of Liver Disease and Digestive Interventional Radiology, Xijing Hospital of Digestive Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: July 24, 2013
• Study Start: September 1, 2013
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

CN (1)