Advanced Adult Hepatocellular CarcinomaPhase 2NCT02418988
Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma
A Phase 2 study testing TACE plus rAd-p53 artery injection and TACE in people with Advanced Adult Hepatocellular Carcinoma, run by Shenzhen SiBiono GeneTech Co.,Ltd at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Adult Hepatocellular Carcinoma
- What is being tested?
- TACE plus rAd-p53 artery injection and TACE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of the Fourth Military Medical University
Xi’an, Shanxi, 710032
xinmin Zhou, MD
About this study
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
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.
Read the 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
- Being tested
- TACE plus rAd-p53 artery injection, TACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE plus rAd-p53 artery injectionDrug
Also called no other name
Trans-catheter chemo-embolization (TACE) with rAd-p53 injection will be given every 21 days
TACEDrug
Also called no other name
Trans-catheter chemo-embolization (TACE) without rAd-p53 injection will be given every 21 days
| Study group | Role | What they receive |
|---|---|---|
| TACE plus rAd-p53 | Experimental | TACE plus rAd-p53 artery injection' Receives: Drug: TACE plus rAd-p53 artery injection |
| TACE | Active comparator | TACE will be applied alone Receives: Drug: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
overall survival
Measured: tumor assessment will be performed every 6 weeks from starting study treatment to death or 2 years later
Secondary outcomes (2)
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
Measured: 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
Measured: tumor assessment will be performed every 6 weeks from starting study treatment to disease progression or 2 years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Adult Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418988
- Sponsor's protocol ID
- rAd-p53-H14006
- Status last verified
- Mar 2015
- First submitted
- 25 Mar 2015
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02418988
- Acronym / sponsor ID
- rAd-p53-H14006
- Conditions
- Advanced Adult Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shenzhen SiBiono GeneTech Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE plus rAd-p53 | Experimental | Drug: TACE plus rAd-p53 artery injectionTACE plus rAd-p53 artery injection' |
| TACE | Active comparator | Drug: TACETACE will be applied alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACE plus rAd-p53 artery injectionAlso: no other nameTrans-catheter chemo-embolization (TACE) with rAd-p53 injection will be given every 21 days | Drug | TACE plus rAd-p53 |
| TACEAlso: no other nameTrans-catheter chemo-embolization (TACE) without rAd-p53 injection will be given every 21 days | Drug | TACE |
Primary outcome
overall survival
Time frame: tumor assessment will be performed every 6 weeks from starting study treatment to death or 2 years later
overall survival
2 secondary outcomes
safety as assessed by 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)
progression-free survival
Time frame: tumor assessment will be performed every 6 weeks from starting study treatment to disease progression or 2 years later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TACE plus rAd-p53 artery injection and TACE in people with Advanced Adult Hepatocellular Carcinoma, run by Shenzhen SiBiono GeneTech Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinming Zhou, MD (0118613991201878, zhouxmm@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: tumor assessment will be performed every 6 weeks from starting study treatment to death or 2 years later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015.