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

NCT ID: NCT02418988

Last Updated: 2015-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-12-31

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)

Conditions

Advanced Adult Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

TACE plus rAd-p53

TACE plus rAd-p53 artery injection'

Group Type: EXPERIMENTAL

TACE plus rAd-p53 artery injection

Intervention Type: DRUG

Trans-catheter chemo-embolization (TACE) with rAd-p53 injection will be given every 21 days

TACE

TACE will be applied alone

Group Type: ACTIVE_COMPARATOR

TACE

Intervention Type: DRUG

Trans-catheter chemo-embolization (TACE) without rAd-p53 injection will be given every 21 days

Interventions

TACE plus rAd-p53 artery injection

Trans-catheter chemo-embolization (TACE) with rAd-p53 injection will be given every 21 days

Intervention Type: DRUG

TACE

Trans-catheter chemo-embolization (TACE) without rAd-p53 injection will be given every 21 days

Intervention Type: DRUG

Other Intervention Names

no other name; no other name

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen SiBiono GeneTech Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xijing Hospital of the Fourth Military Medical University

Xi’an, Shanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xinming Zhou, MD

Role: CONTACT

zhouxmm@fmmu.edu.cn

0118613991201878

Scott Gao, Ph.D, MD

Role: CONTACT

scottgao1110@gmail.com

086-13923759810

Facility Contacts

xinmin Zhou, MD

Role: primary

Other Identifiers

rAd-p53-H14006

Identifier Type: -

Identifier Source: org_study_id