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

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

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.

Study Overview

• Status: Unknown
• Conditions: Advanced Adult Hepatocellular Carcinoma
• Intervention / Treatment: Drug: TACE plus rAd-p53 artery injection; Drug: TACE

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)

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi An, Shanxi, China, 710032
      • Recruiting
      • Xijing hospital of The fourth military medical university
      • Contact: xinmin Zhou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TACE plus rAd-p53; TACE plus rAd-p53 artery injection'	Drug: TACE plus rAd-p53 artery injection; Trans-catheter chemo-embolization (TACE) with rAd-p53 injection will be given every 21 days; Other Names: no other name
Active Comparator: TACE; TACE will be applied alone	Drug: TACE; Trans-catheter chemo-embolization (TACE) without rAd-p53 injection will be given every 21 days; Other Names: no other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	overall survival	tumor assessment will be performed every 6 weeks from starting study treatment to death or 2 years later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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

Collaborators and Investigators

• Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 25, 2015
• First Submitted That Met QC Criteria: April 13, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Estimate): April 17, 2015
• Last Update Submitted That Met QC Criteria: April 13, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Estrogens, Non-Steroidal; Estrogens; Chlorotrianisene
• Other Study ID Numbers: rAd-p53-H14006