Carcinoma, HepatocellularNCT02813096
Study of Folfox4 Chemotherapy Regimen to Prevent Early Postoperative Recurrence for HCC-PVTT Patients
A study testing folfox4 chemotherapy regimen in people with Carcinoma, Hepatocellular, run by Guangxi Medical University.
Trial summary
This study is to investigate the efficacy and safety of Folfox4 chemotherapy regimen to prevent early recurrence for hepatocellular carcinoma patients with portal vein tumor thrombus following curative resection Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- folfox4 chemotherapy regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jul 2018
- Phase
- Interventional
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients undergo curative resection
- HCC with PVTT is confirmed by pathological examination
- patients undergo chemotherapy of Folfox4 regimen
- patients without recurrence within the first month after curative resection
- residual hepatic function is Child-pugh A or B which is capable to tolerate chemotherapy
- patients without other postoperative adjuvant treatments including TACE, radiotherapy, immunotherapy
Who cannot join
- Multipal intra-hepatic or outra-hepatic tastasis within the first month after curative resection
- patients with residual hepatic function Child-pugh C is not capable to tolerate chemotherapy
- patients undergo postoperative adjuvant treatments except chemotherapy of Folfox4 regimen
- patients with badly chemotherapy complications who can finish the whole Folfox4 treatment course
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety Study of Folfox4 Chemotherapy Regimen to Prevent Early Recurrence of Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus Following Curative Resection
This study is to investigate the efficacy and safety of Folfox4 chemotherapy regimen to prevent early recurrence for hepatocellular carcinoma patients with portal vein tumor thrombus following curative resection
Read the detailed description
Curative resective is well-accepted as the predominant treatment for hepatocellular carcinoma (HCC) patients. Unfortunately, the long-term prognosis remains poor due to frequent postoperative recurrence, especially in HCC patients with portal vein tumor thrombus (PVTT). When PVTT invades into the portal vein system, tumor cell spreads and distributes along with the portal vein and its branches,thus resulting in intra-hepatic micro-metastasis which contributes to early recurrence for patients following curative resection. Postoperative adjuvant interventions include TACE, antiviral therapy, immunotherapy, local radiotherapy were applied to prevent recurrence. However, the efficacy and safety of these regimens remains unsatisfactory. Thus new therapeutic strategy remains to be investigated. This study is to investigate the efficacy and safety of Folfox4 chemotherapy regimen to prevent early recurrence for HCC patients with PVTT following curative resection.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- folfox4 chemotherapy regimen, Placebo
- Keywords
- HCC, PVTT, Folofox4, Early Recurrence
- 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.
folfox4 chemotherapy regimenDrug
Also called F4 chemo
Folfox regimen:Oxaliplatin 85 mg/m2 in 250 mL 5% glucose solution, IVD (administered as 2-hour infusion) on day 1;leucovorin 200 mg/m2 in 100 mL 0.9% NaCl solution, IVD (administered as 2-hour infusion) on days 1 and 2; 400 mg/m2 5-FU in 20mL 0.9% NaCl solution, IV(administered as follow leucovorin); then 600 mg/m2 5-FU in 100 mL 0.9% NaCl solution (administered as 22-hour continuous infusion) on days 1 and 2 of each 14 days cycle.
Number of cycles: 4 cycles, or until progression or unacceptable toxicity develops.
PlaceboOther
Also called control
Placebo regimen:250 mL 5% glucose solution, IVD (administered as 2-hour infusion) on day 1; 100 mL 0.9% NaCl solution, IVD (administered as 2-hour infusion) on days 1 and 2; 20mL 0.9% NaCl solution, IV; then 100 mL 0.9% NaCl solution (administered as 22-hour continuous infusion) on days 1 and 2 of each 14 days cycle.
Number of cycles: 4 cycles, or until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| folfox4 chemotherapy regimen | Experimental | details in the "Intervention Description" Receives: Drug: folfox4 chemotherapy regimen |
| Placebo | Placebo comparator | details in the "Intervention Description" Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
early recurrence
Measured: from date of randomization until the first document recurrence from any cause, whichever came first, assessed up to 2 years
Secondary outcomes (1)
overall survival
Measured: from date of randomization until the date of death from any cause, whichever came first, assessed 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 posted24 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiazhou Ye, Guangxi Medical University
- Investigators
- Lequn Li, M.D., Study chair, Cancer Hospital of Guangxi Medical UniversityJiazhou Ye, M.D., Principal investigator, Cancer Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813096
- Sponsor's protocol ID
- GuangxiMUJYe
- Status last verified
- Oct 2016
- First submitted
- 16 Jun 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Folfox4 Chemotherapy Regimen to Prevent Early Recurrence of Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus Following Curative Resection
- ClinicalTrials.gov ID
- NCT02813096
- Acronym / sponsor ID
- GuangxiMUJYe
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- HCC, PVTT, Folofox4, Early Recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 24 Jun 2016 (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 is to investigate the efficacy and safety of Folfox4 chemotherapy regimen to prevent early recurrence for hepatocellular carcinoma patients with portal vein tumor thrombus following curative resection
Detailed description
Curative resective is well-accepted as the predominant treatment for hepatocellular carcinoma (HCC) patients. Unfortunately, the long-term prognosis remains poor due to frequent postoperative recurrence, especially in HCC patients with portal vein tumor thrombus (PVTT). When PVTT invades into the portal vein system, tumor cell spreads and distributes along with the portal vein and its branches,thus resulting in intra-hepatic micro-metastasis which contributes to early recurrence for patients following curative resection. Postoperative adjuvant interventions include TACE, antiviral therapy, immunotherapy, local radiotherapy were applied to prevent recurrence. However, the efficacy and safety of these regimens remains unsatisfactory. Thus new therapeutic strategy remains to be investigated. This study is to investigate the efficacy and safety of Folfox4 chemotherapy regimen to prevent early recurrence for HCC patients with PVTT following curative resection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| folfox4 chemotherapy regimen | Experimental | Drug: folfox4 chemotherapy regimendetails in the "Intervention Description" |
| Placebo | Placebo comparator | Other: Placebodetails in the "Intervention Description" |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- patients undergo curative resection
- HCC with PVTT is confirmed by pathological examination
- patients undergo chemotherapy of Folfox4 regimen
- patients without recurrence within the first month after curative resection
- residual hepatic function is Child-pugh A or B which is capable to tolerate chemotherapy
Key exclusion criteria (4 listed)
- Multipal intra-hepatic or outra-hepatic tastasis within the first month after curative resection
- patients with residual hepatic function Child-pugh C is not capable to tolerate chemotherapy
- patients undergo postoperative adjuvant treatments except chemotherapy of Folfox4 regimen
- patients with badly chemotherapy complications who can finish the whole Folfox4 treatment course
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 |
|---|---|---|
| folfox4 chemotherapy regimenAlso: F4 chemoFolfox regimen:Oxaliplatin 85 mg/m2 in 250 mL 5% glucose solution, IVD (administered as 2-hour infusion) on day 1;leucovorin 200 mg/m2 in 100 mL 0.9% NaCl solution, IVD (administered as 2-hour infusion) on days 1 and 2; 400 mg/m2 5-FU in 20mL 0.9% NaCl solution, IV(administered as follow leucovorin); then 600 mg/m2 5-FU in 100 mL 0.9% NaCl solution (administered as 22-hour continuous infusion) on days 1 and 2 of each 14 days cycle. Number of cycles: 4 cycles, or until progression or unacceptable toxicity develops. | Drug | folfox4 chemotherapy regimen |
| PlaceboAlso: controlPlacebo regimen:250 mL 5% glucose solution, IVD (administered as 2-hour infusion) on day 1; 100 mL 0.9% NaCl solution, IVD (administered as 2-hour infusion) on days 1 and 2; 20mL 0.9% NaCl solution, IV; then 100 mL 0.9% NaCl solution (administered as 22-hour continuous infusion) on days 1 and 2 of each 14 days cycle. Number of cycles: 4 cycles, or until progression or unacceptable toxicity develops. | Other | Placebo |
Primary outcome
early recurrence
Time frame: from date of randomization until the first document recurrence from any cause, whichever came first, assessed up to 2 years
1 secondary outcome
overall survival
Time frame: from date of randomization until the date of death from any cause, whichever came first, assessed up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Lequn Li, M.D. study chair
Cancer Hospital of Guangxi Medical University
Jiazhou Ye, M.D. principal investigator
Cancer Hospital of Guangxi Medical University
Questions about this trial
What is this clinical trial studying?
A study testing folfox4 chemotherapy regimen in people with Carcinoma, Hepatocellular, run by Guangxi Medical University.
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 6 inclusion and 4 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 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Jiazhou Ye, M.D. (+86 13367719078, nnsz20013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early recurrence (time frame: from date of randomization until the first document recurrence from any cause, whichever came first, assessed up to 2 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 25 Oct 2016.