Early Stage Hepatocellular CarcinomaPhase 2NCT01055743
The Effect of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma
A Phase 2 study testing Radical resection and Fluorouracil Implants in people with Early Stage Hepatocellular Carcinoma, run by Simcere Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This study will assess the clinical efficacy and safety of fluorouracil implants regional chemotherapy during the surgical treatment for early-stage hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Early Stage Hepatocellular Carcinoma
- What is being tested?
- Radical resection and Fluorouracil Implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- Aug 2009to Aug 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of stage I hepatocellular carcinoma
- Child-Pugh class A, B
- Radical resection is feasible
- Patients with adequate renal, hepatic, and hematologic function
- Written informed consent
Who cannot join
- Allergic to chemotherapy drugs
- No measurable lesion
- Receive chemotherapy, radiotherapy or biotherapy within 30 days prior to enrollment
- Evidence of serious infection
- Renal or hepatic dysfunction, significant cardiovascular disease
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Shuqun Cheng, MD contact
China1 site, 1 recruiting
- Recruiting
Eastern Hepatobiliary Surgery Hospital
Shanghai, 200438
Shuqun Cheng, MD, 86-021-81875251
Shuqun Cheng, MD
About this study
Official title: A Randomized, Controlled Trial of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma
This study will assess the clinical efficacy and safety of fluorouracil implants regional chemotherapy during the surgical treatment for early-stage hepatocellular carcinoma.
- Conditions
- Early Stage Hepatocellular Carcinoma
- Being tested
- Radical resection, Fluorouracil Implants
- Keywords
- Fluorouracil Implants, Hepatocellular carcinoma, Radical resection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical resectionProcedure or surgery
Radical resection of hepatocellular carcinoma
Fluorouracil ImplantsDrug
Implanted during the surgical treatment
| Study group | Role | What they receive |
|---|---|---|
| Radical resection + Fluorouracil Implants | Experimental | Not described Receives: Procedure: Radical resection; Drug: Fluorouracil Implants |
| Radical resection | Active comparator | Not described Receives: Procedure: Radical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the clinical benefit of fluorouracil implants regional chemotherapy during the radical resection in early stage hepatocellular carcinoma patients. The primary endpoint is disease-free survival (DFS).
Measured: 1, 2, and 3 years
Secondary outcomes (3)
Quality of Life
Measured: from baseline to the last visit
Incidence Rate of Complications
Measured: 1, 2, and 3 years
Adverse Events
Measured: from the beginning of treatment to the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startAug 2009
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simcere Pharmaceutical Co., Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital
- Investigators
- Shuqun Cheng, MD, Principal investigator, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055743
- Sponsor's protocol ID
- 2009PHC001
- Status last verified
- Jan 2010
- First submitted
- 22 Jan 2010
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01055743
- Acronym / sponsor ID
- 2009PHC001
- Conditions
- Early Stage Hepatocellular Carcinoma
- Keywords
- Fluorouracil Implants, Hepatocellular carcinoma, Radical resection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Simcere Pharmaceutical Co., LtdUniversity, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital
- Study start
- Aug 2009
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 26 Jan 2010 (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.
This study will assess the clinical efficacy and safety of fluorouracil implants regional chemotherapy during the surgical treatment for early-stage hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical resection + Fluorouracil Implants | Experimental | Procedure: Radical resection, Drug: Fluorouracil Implants |
| Radical resection | Active comparator | Procedure: Radical resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological diagnosis of stage I hepatocellular carcinoma
- Child-Pugh class A, B
- Radical resection is feasible
- Patients with adequate renal, hepatic, and hematologic function
- Written informed consent
Key exclusion criteria (6 listed)
- Allergic to chemotherapy drugs
- No measurable lesion
- Receive chemotherapy, radiotherapy or biotherapy within 30 days prior to enrollment
- Evidence of serious infection
- Renal or hepatic dysfunction, significant cardiovascular disease
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 |
|---|---|---|
| Radical resectionRadical resection of hepatocellular carcinoma | Procedure or surgery | Radical resection, Radical resection + Fluorouracil Implants |
| Fluorouracil ImplantsImplanted during the surgical treatment | Drug | Radical resection + Fluorouracil Implants |
Primary outcome
To assess the clinical benefit of fluorouracil implants regional chemotherapy during the radical resection in early stage hepatocellular carcinoma patients. The primary endpoint is disease-free survival (DFS).
Time frame: 1, 2, and 3 years
3 secondary outcomes
Quality of Life
Time frame: from baseline to the last visit
Incidence Rate of Complications
Time frame: 1, 2, and 3 years
Adverse Events
Time frame: from the beginning of treatment to the end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2010.
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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.
Shuqun Cheng, MD contact
Shuqun Cheng, MD principal investigator
Eastern Hepatobiliary Surgery Hospital
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 Radical resection and Fluorouracil Implants in people with Early Stage Hepatocellular Carcinoma, run by Simcere Pharmaceutical 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 5 inclusion and 6 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 26 Jan 2010. 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 Shuqun Cheng, MD (86-021-81875251), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the clinical benefit of fluorouracil implants regional chemotherapy during the radical resection in early stage hepatocellular carcinoma patients. The primary endpoint is disease-free survival (DFS). (time frame: 1, 2, and 3 years). 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 26 Jan 2010.