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Phase Ⅲ Trial of Transcatheter Arterial Chemoembolization(TACE) Plus Recombinant Human Adenovirus Type 5 Injection for Unresectable Hepatocellular Carcinoma (HCC)

Phase 3
18 Years
70 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Phase Ⅲ Trial of Transcatheter Arterial Chemoembolization(TACE) Plus Recombinant Human Adenovirus Type 5 Injection for Unresectable Hepatocellular Carcinoma (HCC)

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 were generally poor for HCC patients treated with TACE. Recombinant
Human Adenovirus Type 5, an E1B gene deleted adenovirus, is known to have a significant
antitumor activity. In addition, local injection of recombinant human adenovirus type 5 can
enhance the effect of antitumor therapies (chemotherapy and radiotherapy). The hypothesis is
that patients with unresectable HCC may benefit from recombinant human adenovirus type 5 in
combination with TACE.

Inclusion Criteria:

- Patients newly diagnosed as HCC according to European Association for Study of the
Liver criteria.

- BCLC stage 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

- 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

- 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

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival time

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Ming Shi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Center, Sun Yat-set University


China: Ministry of Health

Study ID:




Start Date:

January 2013

Completion Date:

December 2015

Related Keywords:

  • Hepatocellular Carcinoma
  • TACE
  • Carcinoma,Hepatocellular
  • Liver Neoplasms
  • overall survival
  • Recombinant Human Adenovirus Type 5 Injection
  • Adenoviridae Infections
  • Carcinoma
  • Carcinoma, Hepatocellular