Adult Hepatocellular CarcinomaPhase 2NCT02447679
Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrence
A Phase 2 study testing thalidomine and tegafur-uracil in people with Adult Hepatocellular Carcinoma and Recurrent Hepatocellular Carcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This single-centered phase II clinical study is to obtain preliminary information on 1-year recurrence-free survival rate, recurrence-free survival and safety profile of thalidomide in combination with tegafur-uracil in hepatocellular carcinoma after hepatectomy and explore biomarkers(VEGF/bFGF) for thalidomide… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Adult Hepatocellular Carcinoma, Recurrent Hepatocellular Carcinoma, Adverse Reaction to Drug
- What is being tested?
- thalidomine and tegafur-uracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to 2 Feb 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage I-III（TNM: T1-T3） hepatocellular carcinoma
- previously received curative surgery
- presence at least one and no more than three of the following risk factors ,
- i.Tumor size ≧ 5 cm ii.presence of microscopic or macrovascular venous invasion iii.presence of satellite nodules/addition nodules iv.no capsular formation v.multiple tumors d.performance status of ECOG 0, 1 e.age between 20 and 75 years f.no residual or recurrent tumors detected by computed tomography (CT) or echo within 3-6 weeks after surgery g.written informed consent to participate in the trial
Who cannot join
- other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ prior to the entry of study
- previously received chemotherapy
- less than 2 weeks since previous radiotherapy/surgery
- white blood cell (WBC) less than 3,000/mm3 and absolute neutrophil count (ANC) less than 1,500/mm3, and platelets less than 100,000/mm3
- serum bilirubin greater than 1.5 times the upper limit of normal range (ULN)
- alanine aminotransferase (ALT) or aspartate transaminase (AST) greater than 5 times the ULN
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- alkaline phosphatase greater than 5 times the ULN
- presence of serious concomitant illness which might be aggravated by study medication:uncontrolled infection (active serious infections that are not controlled by antibiotics)
- hypersensitivity to thalidomide or compounds pregnant or breast feeding women, or women of child-bearing potential unless using two reliable and appropriate contraceptive method
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrent After Hepatectomy in High Risk Patients -A Phase II Study
This single-centered phase II clinical study is to obtain preliminary information on 1-year recurrence-free survival rate, recurrence-free survival and safety profile of thalidomide in combination with tegafur-uracil in hepatocellular carcinoma after hepatectomy and explore biomarkers(VEGF/bFGF) for thalidomide response.
Read the detailed description
After liver resection to remove the hepatocellular carcinioma completely, the patients with high risk of tumor recurrence will be enrolled into this study. The high risk of tumor recurrence depends on tumor characteristics. The risk factors of tumor characteristics included tumor size >5 cm in diameter, abscence of encapsulation, vascular invasion and presence of daughter nodules. The patients with high risk of tumor recurrence will have 1 to 3 risk factors. When the patients are enrolled into the study, oral thalidomide in combination with tegafur-uracil will be applied to prevent tumor recurrence. The patients will be fillowed uo erevy 3 mnoths.
- Conditions
- Adult Hepatocellular Carcinoma, Recurrent Hepatocellular Carcinoma, Adverse Reaction to Drug, Vascular Endothelial Growth Factor Overexpression
- Being tested
- thalidomine, tegafur-uracil
- Medical subject headings
- Carcinoma, Hepatocellular, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thalidomineDrug
Also called thado
thalidomine (400mg/day) for 1 year to prevent HCC recurrence
tegafur-uracilDrug
Also called ufur
tegafur-uracil (2 tablelet twice a day) for 1 year to prevent HCC recurrence
| Study group | Role | What they receive |
|---|---|---|
| thalidomine | Experimental | 1. Thalidomide 400mg/day for 1 year
2. tegafur-uracil 2 tables for 1 year. Receives: Drug: thalidomine; Drug: tegafur-uracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor recurrence
Measure a-fetoprotein and perform liver echo to find out tumor recurrence every 3 month. Then, if a tumor/tumors are found in liver echo, tumor recurrence will be confirmed by CT scan. The imaging on CT shows typical HCC pattern.
The pilot study is to obtain preliminary information on:
- 3-year recurrence-free survival rate
- Recurrence-free survival
- Safety profile of the treatment
- Biomarkers response(VEGF/bFGF)
Measured: every 3 months, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startAug 2010
- Primary completion31 Jan 2017
- Study completion2 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Chen Lee, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447679
- Sponsor's protocol ID
- CGMF-IRB-97-1291A
- Status last verified
- Dec 2016
- First submitted
- 16 Dec 2014
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrent After Hepatectomy in High Risk Patients -A Phase II Study
- ClinicalTrials.gov ID
- NCT02447679
- Acronym / sponsor ID
- CGMF-IRB-97-1291A
- Conditions
- Adult Hepatocellular Carcinoma, Recurrent Hepatocellular Carcinoma, Adverse Reaction to Drug, Vascular Endothelial Growth Factor Overexpression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 19 May 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.
This single-centered phase II clinical study is to obtain preliminary information on 1-year recurrence-free survival rate, recurrence-free survival and safety profile of thalidomide in combination with tegafur-uracil in hepatocellular carcinoma after hepatectomy and explore biomarkers(VEGF/bFGF) for thalidomide response.
Detailed description
After liver resection to remove the hepatocellular carcinioma completely, the patients with high risk of tumor recurrence will be enrolled into this study. The high risk of tumor recurrence depends on tumor characteristics. The risk factors of tumor characteristics included tumor size >5 cm in diameter, abscence of encapsulation, vascular invasion and presence of daughter nodules. The patients with high risk of tumor recurrence will have 1 to 3 risk factors. When the patients are enrolled into the study, oral thalidomide in combination with tegafur-uracil will be applied to prevent tumor recurrence. The patients will be fillowed uo erevy 3 mnoths.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thalidomine | Experimental | Drug: thalidomine, Drug: tegafur-uracil1. Thalidomide 400mg/day for 1 year 2. tegafur-uracil 2 tables for 1 year. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- stage I-III（TNM: T1-T3） hepatocellular carcinoma
- previously received curative surgery
- presence at least one and no more than three of the following risk factors ,
- i.Tumor size ≧ 5 cm ii.presence of microscopic or macrovascular venous invasion iii.presence of satellite nodules/addition nodules iv.no capsular formation v.multiple tumors d.performance status of ECOG 0, 1 e.age between 20 and 75 years f.no residual or recurrent tumors detected by computed tomography (CT) or echo within 3-6 weeks after surgery g.written informed consent to participate in the trial
Key exclusion criteria (9 listed)
- other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ prior to the entry of study
- previously received chemotherapy
- less than 2 weeks since previous radiotherapy/surgery
- white blood cell (WBC) less than 3,000/mm3 and absolute neutrophil count (ANC) less than 1,500/mm3, and platelets less than 100,000/mm3
- serum bilirubin greater than 1.5 times the upper limit of normal range (ULN)
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 |
|---|---|---|
| thalidomineAlso: thadothalidomine (400mg/day) for 1 year to prevent HCC recurrence | Drug | thalidomine |
| tegafur-uracilAlso: ufurtegafur-uracil (2 tablelet twice a day) for 1 year to prevent HCC recurrence | Drug | thalidomine |
Primary outcome
tumor recurrence
Time frame: every 3 months, up to 5 years
Measure a-fetoprotein and perform liver echo to find out tumor recurrence every 3 month. Then, if a tumor/tumors are found in liver echo, tumor recurrence will be confirmed by CT scan. The imaging on CT shows typical HCC pattern. The pilot study is to obtain preliminary information on: * 3-year recurrence-free survival rate * Recurrence-free survival * Safety profile of the treatment * Biomarkers response(VEGF/bFGF)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
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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.
Wei-Chen Lee principal investigator
Chang Gung Memorial 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 thalidomine and tegafur-uracil in people with Adult Hepatocellular Carcinoma and Recurrent Hepatocellular Carcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 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: finished, as of the sponsor's last update on 7 Feb 2017. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor recurrence (time frame: every 3 months, up to 5 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 7 Feb 2017.