TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma

• Status: Unknown status
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Pregnant or lactating women.

• Active sepsis or bleeding.

• Hypersensitivity to intravenous contrast agents.

• The patient has received prior treatment for HCC target lesion.

• History of cardiac disease

• Congestive heart failure > NYHA class 2; active coronary artery disease

• Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.

• Hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management.

• Serious non-healing wounds (including wounds healing by secondary intention), acute or non-healing ulcers, or bone fractures within 3 months.

• The patient is, in the opinion of the investigator, unable and / or unwilling to comply with treatment and study instructions.

• Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.

• Any active clinically serious infections (> grade 2 NCI-CTCAE ver 3.0)

• HIV infection or AIDS-related illness or serious acute or chronic illness (based on medical history)