Hepatocellular CarcinomaPhase 3NCT01936233
Clinical Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery
A Phase 3 study testing Aspirin and Lamivudine in people with Hepatocellular Carcinoma and Recurrence, run by Fudan University at 1 site in China.
Trial summary
Evaluation the Treatment Outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Recurrence
- What is being tested?
- Aspirin and Lamivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Dec 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
- Age ≥ 18 years and ≤ 75 years
- At least one tumor nodule with one uni-dimension of ≥ 2 cm
- Child-Pugh Class A or B
- HBV-DNA>10^4
- Total bilirubin ≤ 1.5 x upper limit of normal
Show all 13Show fewer
- ALT and AST ≤ 2.0 x the upper limit of normal
- PT-INR<2.3,PTT < 1.5 x upper limit of normal
- Serum creatinine ≤ 1.5x upper limit of normal
- Peripheral white blood cell count of or more than 3×10(9)/L
- Peripheral platelet of or more than 50×10(9)/L
- Expected survival time not less than 3 months
- ECOG score 0-2
Who cannot join
- Tumor thrombi in main branch of portal vein
- Tumor involvement more than 70% of whole liver
- With extrahepatic metastasis
- Prior systemic chemotherapy or chemoembolization
- Congestive heart failure > NYHA class 2
- History of HIV infection
Show all 14Show fewer
- Active clinically serious infections (> 2 NCI-CTC Version 3.0)
- Recurrence of HCC after liver transplantation
- Pregnant or breast-feeding
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
- Known or suspected allergy to any agent given in association with this trial
- Patients unable to swallow oral medication
- Inclined to thrombosis
- Inclined to hemorrhage or active hemorrhage with 1 month
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liver Cancer Institute
Shanghai, Shanghai Municipality, 200032
Zheng-Gang Ren, Ph.D, 0086-021-64041990 ext. 2149, ren.zhenggang@zs-hospital.sh.cn
Lan Zhang, Master, 0086-021-64041990 ext. 2971, zhang.lan@zs-hospital.sh.cn
About this study
Official title: Liver Cancer Institiute ,Fudan University
Evaluation the Treatment Outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.
Read the detailed description
The investigators conduct this clinical trial to evaluate the treatment outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.The primary outcome is overall survival and objective response rate.
- Conditions
- Hepatocellular Carcinoma, Recurrence
- Being tested
- Aspirin, Lamivudine
- Keywords
- Hepatocellular Carcinoma, Aspirin, antiviral treatment, recurrence free survival, radical therapy
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Aspirin 0.1 QD po
LamivudineDrug
LAminvudine 0.1 QD po
| Study group | Role | What they receive |
|---|---|---|
| Aspirin AND Lamivudine | Experimental | Not described Receives: Drug: Aspirin; Drug: Lamivudine |
| Lamivudine | Active comparator | Not described Receives: Drug: Lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence free survival
Measured: 36 months
Secondary outcomes (2)
overall survival
Measured: 36 months
adverse events
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2021 (estimated)
- Study completionDec 2023 (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 Fudan UniversityThe 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
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng-Gang Ren, Fudan University
- Investigators
- Zhenggang Ren, Ph.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936233
- Sponsor's protocol ID
- LC-ASPIRIN
- Status last verified
- Dec 2018
- First submitted
- 2 Sep 2013
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Cancer Institiute ,Fudan University
- ClinicalTrials.gov ID
- NCT01936233
- Acronym / sponsor ID
- LC-ASPIRIN
- Conditions
- Hepatocellular Carcinoma, Recurrence
- Keywords
- Hepatocellular Carcinoma, Aspirin, antiviral treatment, recurrence free survival, radical therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Sep 2013 (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.
Evaluation the Treatment Outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.
Detailed description
The investigators conduct this clinical trial to evaluate the treatment outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.The primary outcome is overall survival and objective response rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin AND Lamivudine | Experimental | Drug: Aspirin, Drug: Lamivudine |
| Lamivudine | Active comparator | Drug: Lamivudine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
- Age ≥ 18 years and ≤ 75 years
- At least one tumor nodule with one uni-dimension of ≥ 2 cm
- Child-Pugh Class A or B
- HBV-DNA>10^4
Key exclusion criteria (14 listed)
- Tumor thrombi in main branch of portal vein
- Tumor involvement more than 70% of whole liver
- With extrahepatic metastasis
- Prior systemic chemotherapy or chemoembolization
- Congestive heart failure > NYHA class 2
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 |
|---|---|---|
| AspirinAspirin 0.1 QD po | Drug | Aspirin AND Lamivudine |
| LamivudineLAminvudine 0.1 QD po | Drug | Aspirin AND Lamivudine, Lamivudine |
Primary outcome
recurrence free survival
Time frame: 36 months
2 secondary outcomes
overall survival
Time frame: 36 months
adverse events
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Zhenggang Ren, Ph.D principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin and Lamivudine in people with Hepatocellular Carcinoma and Recurrence, run by Fudan University 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 13 inclusion and 14 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 5 Aug 2019. 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 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 Zheng-Gang Ren, Ph.D (0086-021-64041990 ext. 2149, ren.zhenggang@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence free survival (time frame: 36 months). 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 5 Aug 2019.