TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma

NCT01869088 | Unknown Phase 3 DMC

• 1 other identifier: HCC-120402
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if TACE plus Recombinant Human Adenovirus Type 5 Injection will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery or local ablative therapy.

Conditions

Hepatocellular Carcinoma

Keywords

TACE; Carcinoma,Hepatocellular; Liver Neoplasms; overall survival; Recombinant Human Adenovirus Type 5 Injection

Outcome Measures

Primary Outcomes (1)

• Overall survival time

  3 years

Secondary Outcomes (2)

• Number of adverse events

  30 days

• Tumor response

  12 weeks

Study Arms (2)

TACE Only

ACTIVE COMPARATOR

TACE with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg)and followed with embolization with lipiodol or/and polyvinyl alcohol particles.

Procedure: Transartery Chemoembolization

TACE Plus Adenovirus

EXPERIMENTAL

After identifying the target artery of HCC, Recombinant Human Adenovirus Type 5 Injection（15.0\*1011vp：0.5ml\*3） will be first infused through the target artery of HCC patient and followed with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg) and lipiodol emulsion or/and polyvinyl alcohol particles(dependent on the tumor size) Procedure: TACE (Transcatheter arterial chemoembolization)

Drug: Recombinant Human Adenovirus Type 5 Injection; Procedure: Transartery Chemoembolization

Interventions

Recombinant Human Adenovirus Type 5 Injection DRUG

After identifying the target artery of HCC, Recombinant Human Adenovirus Type 5 Injection（15.0\*1011vp：0.5ml\*3） will be first infused through the target artery

TACE Plus Adenovirus

Transartery Chemoembolization PROCEDURE

Transartery chemoembolization with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg)and followed with embolization with lipiodol or/and polyvinyl alcohol particles.

TACE Only; TACE Plus Adenovirus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
• BCLC stage A or B
• Child-Pugh class A or B (Child-Pugh score 7)
• ECOG performance status of 0
• Patients must have at least one tumor lesion that meets both of the following criteria:
• The lesion can be accurately measured in at least one dimension according to RECIST criteria
• The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
• Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) to non-target lesions are eligible
• Local therapy must have been completed at least 4 weeks prior to baseline scan.
• Haematology:Absolute neutrophil count (ANC) \> 1 x 109/L, Platelet count \> 40 x 109/L, Haemoglobin \> 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio \< 1.5
• Biochemistry:Total bilirubin \< 2 mg/dL Serum creatinine \< 1.5 x the upper limit of normal
• Ability to understand the protocol and to agree to and sign a written informed consent document

You may not qualify if:

• Tumor factors
• Presence of extrahepatic metastasis
• Predominantly infiltrative lesion
• Diffuse tumor morphology with extensive lesions involving both lobes.
• Vascular complications
• Hepatic artery thrombosis, or
• Partial or complete thrombosis of the main portal vein, or
• Tumor invasion of portal branch of contralateral lobe, or
• Hepatic vein tumor thrombus, or
• Significant arterioportal shunt not amenable to shunt blockage
• Liver function
• Advanced liver disease: ascites, hepatic encephalopathy
• Patients with clinically significant gastrointestinal bleeding within the 30 days prior to study entry.
• Others
• Renal failure requiring hemo- or peritoneal dialysis

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Related Publications (32)

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MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ming Shi, MD

  Cancer Center, Sun Yat-set University

  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: February 16, 2013
• First Posted: June 5, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 16, 2017

Record last verified: 2017-03

Locations

CN (1)