Hepatocellular CarcinomaPhase 3NCT03313596
Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC
A Phase 3 study testing ADV-Tk and LT in people with Hepatocellular Carcinoma, run by Huazhong University of Science and Technology at 11 sites in China.
Trial summary
Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy versus LT only in advanced primary hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- ADV-Tk and LT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 11 sitesChina
- Study dates
- Mar 2013to Dec 2019
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 65 years of age (Male and Female).
- Clinical diagnosis of advanced primary hepatocellular carcinoma who could accept liver transplantation.
- Patients who had unresectable HCC with single tumor diameter > 5 cm and ≤ 10cm; or numbers of multiple tumors >3 and ≤ 5, and the total length of foci diameter ≤ 15 cm.
- Serum AFP ≤ 10000 ng/ml before liver transplantation.
- Child-pugh A-B.
- No metastasis in extrahepatic main vescular and extrahepatic lymph node detected during the operation and no metastasis of other organs.
- Provide written informed consent before screening.
Who cannot join
- Metastasis in extrahepatic organs.
- HCC with Invasion in extrahepatic main vescular and extrahepatic organs.
- Contraindications of operation of other organ system.
- Hypersensitivity to adenovirus, GCV or similar drugs.
- Serious obstacle of the mechanism of coagulation, hemorrhagic tendency, and abnormal coagulation (≥50%).
- Plan to accept clinical trials of other antitumor drugs.
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- Immunological deficit.
- HBsAg(+) and HBcAb(+) donor.
- Unsuitable participate assessed by investigator.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Beijing Youan Hospital
Beijing, Beijing Municipality, 10001
Ning Li, Dr
- Recruiting
301 Military Hospital
Beijing
Jiahong Dong
- Recruiting
General Hospital of Chinese People's Armed Police
Beijing
Yunjin Zang
- Recruiting
The Third XiangYa Hospital of Central South University
Changsha
Qifa Ye
- Recruiting
West China Hospital of Sichuan University
Chengdu
Lvnan Yan
- Recruiting
The Third Affiliated Hospital,Sun Yat-sen University
Guangzhou
Guihua Chen
- Recruiting
The First Affiliated Hospital, Zhejiang University
Hangzhou
Shusen Zheng
- Recruiting
Zhongshan Hospital of Fudan University
Shanghai
Jia Fan
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang
Yongfeng Liu
- Recruiting
The First Center Hospital of Tianjin
Tianjin
Zhongyang Shen
- Recruiting
The First Hospital of Xinjiang Medical University
Ürümqi
Hao Wen
About this study
Official title: Multicenter Randomized Controlled Trial of Adenovirus-mediated Adjuvant Gene Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy versus LT only in advanced primary hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- ADV-Tk, LT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADV-TkDrug
The first ADV-TK dose was administered during the operation; 1.0×10(12) viral particles of ADV-TK in 100 mL of 0.9% saline were injected into peritoneum tissues around the liver. The second and third ADV-TK dose was administered 60 days and 90 days after LT; 1.0×10(12) viral particles of ADV-TK in 100 mL of 0.9% saline were injected into the celiac artery (60 mL) and the superior mesenteric artery (40 mL) via femoral-artery puncture.
LTProcedure or surgery
Orthotopic LT and subsequent immunosuppression therapy
| Study group | Role | What they receive |
|---|---|---|
| LT-only | Active comparator | patients received orthotopic LT and subsequent immunosuppression therapy Receives: Procedure: LT |
| LT+ADV-TK | Experimental | ADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy Receives: Drug: ADV-Tk; Procedure: LT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival, PFS
PFS was measured from the day of liver transplantation to objective recurrence (MRI or CT) or HCC-related death, whichever occurred first.
Measured: 2-year
Secondary outcomes (4)
Overall survival, OS
OS was measured from the day of liver transplantation to death.
Measured: 1-year
Overall survival, OS
OS was measured from the day of liver transplantation to death.
Measured: 2-year
Time of the tumor progression,TTP
TTP was the median period from the day of liver transplantation to objective recurrence (MRI or CT).
Measured: 2-year
Median overall survival time
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study startMar 2013
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing YouAn Hospital
- Responsible party
- Principal investigator, Ding Ma, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313596
- Sponsor's protocol ID
- LT-03
- Status last verified
- Feb 2019
- First submitted
- 8 Oct 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial of Adenovirus-mediated Adjuvant Gene Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03313596
- Acronym / sponsor ID
- LT-03
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Beijing YouAn Hospital
- Study start
- Mar 2013
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Oct 2017 (actual)
- 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.
Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy versus LT only in advanced primary hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LT-only | Active comparator | Procedure: LTpatients received orthotopic LT and subsequent immunosuppression therapy |
| LT+ADV-TK | Experimental | Drug: ADV-Tk, Procedure: LTADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 - 65 years of age (Male and Female).
- Clinical diagnosis of advanced primary hepatocellular carcinoma who could accept liver transplantation.
- Patients who had unresectable HCC with single tumor diameter > 5 cm and ≤ 10cm; or numbers of multiple tumors >3 and ≤ 5, and the total length of foci diameter ≤ 15 cm.
- Serum AFP ≤ 10000 ng/ml before liver transplantation.
- Child-pugh A-B.
Key exclusion criteria (9 listed)
- Metastasis in extrahepatic organs.
- HCC with Invasion in extrahepatic main vescular and extrahepatic organs.
- Contraindications of operation of other organ system.
- Hypersensitivity to adenovirus, GCV or similar drugs.
- Serious obstacle of the mechanism of coagulation, hemorrhagic tendency, and abnormal coagulation (≥50%).
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 |
|---|---|---|
| ADV-TkThe first ADV-TK dose was administered during the operation; 1.0×10(12) viral particles of ADV-TK in 100 mL of 0.9% saline were injected into peritoneum tissues around the liver. The second and third ADV-TK dose was administered 60 days and 90 days after LT; 1.0×10(12) viral particles of ADV-TK in 100 mL of 0.9% saline were injected into the celiac artery (60 mL) and the superior mesenteric artery (40 mL) via femoral-artery puncture. | Drug | LT+ADV-TK |
| LTOrthotopic LT and subsequent immunosuppression therapy | Procedure or surgery | LT+ADV-TK, LT-only |
Primary outcome
Progression-free survival, PFS
Time frame: 2-year
PFS was measured from the day of liver transplantation to objective recurrence (MRI or CT) or HCC-related death, whichever occurred first.
4 secondary outcomes
Overall survival, OS
Time frame: 1-year
Overall survival, OS
Time frame: 2-year
Time of the tumor progression,TTP
Time frame: 2-year
Median overall survival time
Time frame: 2-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ADV-Tk and LT in people with Hepatocellular Carcinoma, run by Huazhong University of Science and Technology at 11 sites 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 9 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Danhui Weng, Dr. (027-83663351, weng.dh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival, PFS (time frame: 2-year). 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 4 Feb 2019.