Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma

Advanced Adult Hepatocellular Carcinoma Clinical Trial

Official title:

Multicenter, Open-labeled, Controlled Phase II Study: Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02418988
• Other study ID #: rAd-p53-H14006
• Status: Recruiting
• Phase: Phase 2
• First received: March 25, 2015
• Last updated: April 13, 2015
• Start date: July 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2015
• Source: Shenzhen SiBiono GeneTech Co.,Ltd
• Contact: Xinming Zhou, MD
• Phone: 0118613991201878
• Email: zhouxmm[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Advanced Adult Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• TACE plus rAd-p53 artery injection
Trans-catheter chemo-embolization (TACE) with rAd-p53 injection will be given every 21 days
• TACE
Trans-catheter chemo-embolization (TACE) without rAd-p53 injection will be given every 21 days

Locations

Country	Name	City	State
China	Xijing Hospital of the Fourth Military Medical University	Xi An	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen SiBiono GeneTech Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	overall survival	tumor assessment will be performed every 6 weeks from starting study treatment to death or 2 years later	No
Secondary	safety as assessed by adverse events, vital sign, lab tests, ECG and physical examination	safety variables: 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)	Yes
Secondary	progression-free survival	time to disease progression (death or progression), or censored	tumor assessment will be performed every 6 weeks from starting study treatment to disease progression or 2 years later	No