Hepatocellular CarcinomaPhase 3NCT00921531
Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma
A Phase 3 study testing Thalidomide and TACE in people with Hepatocellular Carcinoma, run by Fudan University at 1 site in China.
Trial summary
Chemoembolization (TACE) is used in the majority of advanced hepatocellular carcinomas. Randomized clinical trials indicated that TACE improves overall survival in patients with good liver function (Child-pugh A or B). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Thalidomide and TACE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to Apr 2013
- 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 80 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 ≤ 80 years
- At least one tumor nodule with one uni-dimension of ≥ 2 cm
- Child-Pugh Class A or B
- Total bilirubin ≤ 1.5 x upper limit of normal
- ALT and AST ≤ 2.0 x the upper limit of normal
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- 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
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- 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. 2137, ren.zhenggang@zs-hospital.sh.cn
Lan Zhang, Master, 0086-021-64041990 ext. 2171, zhang.lan@zs-hospital.sh.cn
About this study
Official title: Phase Ⅲ Study of Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma
Chemoembolization (TACE) is used in the majority of advanced hepatocellular carcinomas. Randomized clinical trials indicated that TACE improves overall survival in patients with good liver function (Child-pugh A or B). However, the shortcoming of TACE is obvious: hypoxia induced neoangiogenesis after blockage of blood supply of the tumor; repeat TACE deteriorates liver cirrhosis due to toxicity of chemotherapeutic agent to the parenchyma liver. Thalidomide has been reported to have antiangiogenic and antimetastatic effects. The objectives of adjuvant therapy with thalidomide for chemoembolization is to evaluate overall survival and time to progression.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Thalidomide, TACE
- Keywords
- Hepatocellular carcinoma, thalidomide, TACE, Child-Pugh Class A or B
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Thalidomide is used for adjuvant therapy for TACE
Thalidomide will be given at the dose of 200 mg/day in beginning, with dose escalation of 100 mg/day each week, until to the dosage of 400 mg/day.
TACEDrug
TACE (5-FU 1.0 g, OXP 150mg, MMC 10 mg, lipiodol 5-30 ml) will be performed every two months (defined as a course) until no radiological evidence of survival of tumor (based on contrast MRI) or 6 courses.
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide and TACE | Experimental | Thalidomide is used for adjuvant therapy for TACE Receives: Drug: Thalidomide; Drug: TACE |
| TACE only | Active comparator | Not described Receives: Drug: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
primary outcome is defined as overall survival. overall survival is calculated from the time of undergo treatment (TACE) to time of patients death.
Measured: 36 months
Secondary outcomes (1)
time to progression
time to progression is defined as from the time of treatment (TACE) to the time of patient's progression. the progression is defined as disease progression based on RECIST criteria.
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 posted16 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2012 (estimated)
- Study completionApr 2013 (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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921531
- Sponsor's protocol ID
- LCI-THALIDOMIDE
- Other IDs
- LCI-09-06-15
- Status last verified
- Jun 2009
- First submitted
- 15 Jun 2009
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅲ Study of Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00921531
- Acronym / sponsor ID
- LCI-THALIDOMIDE
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, thalidomide, TACE, Child-Pugh Class A or B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 16 Jun 2009 (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.
Chemoembolization (TACE) is used in the majority of advanced hepatocellular carcinomas. Randomized clinical trials indicated that TACE improves overall survival in patients with good liver function (Child-pugh A or B). However, the shortcoming of TACE is obvious: hypoxia induced neoangiogenesis after blockage of blood supply of the tumor; repeat TACE deteriorates liver cirrhosis due to toxicity of chemotherapeutic agent to the parenchyma liver. Thalidomide has been reported to have antiangiogenic and antimetastatic effects. The objectives of adjuvant therapy with thalidomide for chemoembolization is to evaluate overall survival and time to progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thalidomide and TACE | Experimental | Drug: Thalidomide, Drug: TACEThalidomide is used for adjuvant therapy for TACE |
| TACE only | Active comparator | Drug: TACE |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
- Age ≥ 18 years and ≤ 80 years
- At least one tumor nodule with one uni-dimension of ≥ 2 cm
- Child-Pugh Class A or B
- Total bilirubin ≤ 1.5 x upper limit of normal
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 |
|---|---|---|
| ThalidomideThalidomide is used for adjuvant therapy for TACE Thalidomide will be given at the dose of 200 mg/day in beginning, with dose escalation of 100 mg/day each week, until to the dosage of 400 mg/day. | Drug | Thalidomide and TACE |
| TACETACE (5-FU 1.0 g, OXP 150mg, MMC 10 mg, lipiodol 5-30 ml) will be performed every two months (defined as a course) until no radiological evidence of survival of tumor (based on contrast MRI) or 6 courses. | Drug | TACE only, Thalidomide and TACE |
Primary outcome
Overall survival
Time frame: 36 months
primary outcome is defined as overall survival. overall survival is calculated from the time of undergo treatment (TACE) to time of patients death.
1 secondary outcome
time to progression
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 19 Apr 2011.
- Fudan University,Shanghai,ChinaLink provided by the sponsor.
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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 3 study testing Thalidomide and TACE in people with Hepatocellular Carcinoma, 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 12 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 19 Apr 2011. 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. 2137, 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?
Overall 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 19 Apr 2011.