Status:
UNKNOWN
TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 surge...
Detailed Description
Transarterial chemoembolization (TACE) is currently one of the mainstays of palliative treatments worldwide for patients with unresectable Hepatocellular Carcinoma(HCC).However, the long term outcomes...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2018
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT01869088
Start Date
January 1 2013
End Date
January 1 2018
Last Update
March 16 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China