Advanced Adult Hepatocellular Carcinoma
Conditions
Brief summary
Treatment options for advanced hepatocellular carcinoma (HCC) are limited due to patients' poor condition, advanced tumor, concomitant intra- and extra-liver diseases, and resistance to both chemo- and radio-therapy. Trans-catheter embolization (TAE) or Trans-catheter chemo-embolization (TACE) is the most widely used locoregional treatment for advanced HCC. But no solid evidences support the beneficial effect of the chemotherapy in TACE. Many advanced HCC patients also can't tolerate the locoregional chemotherapy. The p53 gene has multiple anticancer functions and does not have any of the immune-inhibitory effects of chemo- or radio-therapy. The objectives of this study are to investigate the efficacy and safety usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced HCC.
Detailed description
Study design: multicenter, open-labeled, active-controlled phase II study Study treatments: TACE combined with rAd-p53 injection vs.TACE. The treatments are given once per 21 days until the disease progression. For the experiment group, 2 X 1000,000,000,000 viral particles of rAd-p53 will be injected into the embolization artery. Study objectives: efficacy and safety of the study treatments Study endpoints: safety (adverse events, vital signs, lab tests, ECG and physical examination) and efficacy (progression-free survival, overall survival, and ECOG PS)
Interventions
DRUGTACE plus rAd-p53 artery injection
Trans-catheter chemo-embolization (TACE) with rAd-p53 injection will be given every 21 days
DRUGTACE
Trans-catheter chemo-embolization (TACE) without rAd-p53 injection will be given every 21 days
Sponsors
Shenzhen SiBiono GeneTech Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. histopathologically diagnosed HCC; 2. unresectable; 3. over 18 years old; 4. with an Eastern Cooperative Oncology Group (ECOG) score of 0-2; 5. with Barcelona Clinic Liver Cancer (BCLC) Stage of B or C; 6. with Child-Pugh score A or B; 7. with normal tests of hemogram, blood coagulation, liver and kidney function; 8. signed the informed consent form.
Exclusion criteria
1. Serious blood coagulation disorder, bleeding tendency, platelet \< 6 \* 1000000000/L; 2. have serious heart, lung function abnormalities or severe diabetes patients; 3. active infection; 4. liver function Child-Pugh grade C; 5. secondary and diffuse hepatocellular carcinoma patients; 6. extensive metastasis; 7. severe atherosclerosis; 8. AIDS patients; 9. serious thrombotic or embolic events within 6 months; 10. renal insufficiency requiring hemodialysis or peritoneal dialysis; 12\. pregnant or lactating women; 13\. mental disorder or disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | tumor assessment will be performed every 6 weeks from starting study treatment to death or 2 years later | overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety as assessed by adverse events, vital sign, lab tests, ECG and physical examination | from the first study treatment to the 30 days after the last treatment (on an average of 6 months from the start treatment) | safety variables: adverse events, vital sign, lab tests, ECG and physical examination |
| progression-free survival | tumor assessment will be performed every 6 weeks from starting study treatment to disease progression or 2 years later | time to disease progression (death or progression), or censored |
Countries
China
Contacts
Primary ContactXinming Zhou, MD
Backup ContactScott Gao, Ph.D, MD
Outcome results
None listed