Back to resultsTrans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma
Primary Purpose
Advanced Adult Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TACE plus rAd-p53 artery injection
TACE
Sponsored by
About this trial
This is an interventional prevention trial for Advanced Adult Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- histopathologically diagnosed HCC;
- unresectable;
- over 18 years old;
- with an Eastern Cooperative Oncology Group (ECOG) score of 0-2;
- with Barcelona Clinic Liver Cancer (BCLC) Stage of B or C;
- with Child-Pugh score A or B;
- with normal tests of hemogram, blood coagulation, liver and kidney function; 8. signed the informed consent form.
Exclusion Criteria:
- Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L;
- have serious heart, lung function abnormalities or severe diabetes patients;
- active infection;
- liver function Child-Pugh grade C;
- secondary and diffuse hepatocellular carcinoma patients;
- extensive metastasis;
- severe atherosclerosis;
- AIDS patients;
- serious thrombotic or embolic events within 6 months;
- renal insufficiency requiring hemodialysis or peritoneal dialysis;
12. pregnant or lactating women;
13. mental disorder or disease.
Sites / Locations
- Xijing Hospital of the Fourth Military Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TACE plus rAd-p53
TACE
Arm Description
TACE plus rAd-p53 artery injection'
TACE will be applied alone
Outcomes
Primary Outcome Measures
overall survival
overall survival
Secondary Outcome Measures
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
progression-free survival
time to disease progression (death or progression), or censored
Full Information
NCT ID
NCT02418988
First Posted
March 25, 2015
Last Updated
April 13, 2015
Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02418988
Brief Title
Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Adult Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TACE plus rAd-p53
Arm Type
Experimental
Arm Description
TACE plus rAd-p53 artery injection'
Arm Title
TACE
Arm Type
Active Comparator
Arm Description
TACE will be applied alone
Intervention Type
Drug
Intervention Name(s)
TACE plus rAd-p53 artery injection
Other Intervention Name(s)
no other name
Intervention Description
Trans-catheter chemo-embolization (TACE) with rAd-p53 injection will be given every 21 days
Intervention Type
Drug
Intervention Name(s)
TACE
Other Intervention Name(s)
no other name
Intervention Description
Trans-catheter chemo-embolization (TACE) without rAd-p53 injection will be given every 21 days
Primary Outcome Measure Information:
Title
overall survival
Description
overall survival
Time Frame
tumor assessment will be performed every 6 weeks from starting study treatment to death or 2 years later
Secondary Outcome Measure Information:
Title
safety as assessed by adverse events, vital sign, lab tests, ECG and physical examination
Description
safety variables: adverse events, vital sign, lab tests, ECG and physical examination
Time Frame
from the first study treatment to the 30 days after the last treatment (on an average of 6 months from the start treatment)
Title
progression-free survival
Description
time to disease progression (death or progression), or censored
Time Frame
tumor assessment will be performed every 6 weeks from starting study treatment to disease progression or 2 years later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histopathologically diagnosed HCC;
unresectable;
over 18 years old;
with an Eastern Cooperative Oncology Group (ECOG) score of 0-2;
with Barcelona Clinic Liver Cancer (BCLC) Stage of B or C;
with Child-Pugh score A or B;
with normal tests of hemogram, blood coagulation, liver and kidney function; 8. signed the informed consent form.
Exclusion Criteria:
Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L;
have serious heart, lung function abnormalities or severe diabetes patients;
active infection;
liver function Child-Pugh grade C;
secondary and diffuse hepatocellular carcinoma patients;
extensive metastasis;
severe atherosclerosis;
AIDS patients;
serious thrombotic or embolic events within 6 months;
renal insufficiency requiring hemodialysis or peritoneal dialysis;
12. pregnant or lactating women;
13. mental disorder or disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinming Zhou, MD
Phone
0118613991201878
Email
zhouxmm@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Gao, Ph.D, MD
Phone
086-13923759810
Email
scottgao1110@gmail.com
Facility Information:
Facility Name
Xijing Hospital of the Fourth Military Medical University
City
Xi An
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xinmin Zhou, MD
12. IPD Sharing Statement
Learn more about this trial
Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma
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