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Study of Folfox4 Chemotherapy Regimen to Prevent Early Postoperative Recurrence for HCC-PVTT Patients

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ClinicalTrials.gov Identifier: NCT02813096
Recruitment Status : Unknown
Verified October 2016 by Jiazhou Ye, Guangxi Medical University.
Recruitment status was:  Not yet recruiting
First Posted : June 24, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Jiazhou Ye, Guangxi Medical University

Tracking Information
First Submitted Date  ICMJE June 16, 2016
First Posted Date  ICMJE June 24, 2016
Last Update Posted Date October 25, 2016
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
early recurrence [ Time Frame: from date of randomization until the first document recurrence from any cause, whichever came first, assessed up to 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
overall survival [ Time Frame: from date of randomization until the date of death from any cause, whichever came first, assessed up to 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Folfox4 Chemotherapy Regimen to Prevent Early Postoperative Recurrence for HCC-PVTT Patients
Official Title  ICMJE Efficacy and Safety Study of Folfox4 Chemotherapy Regimen to Prevent Early Recurrence of Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus Following Curative Resection
Brief 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Carcinoma, Hepatocellular
Intervention  ICMJE
  • Drug: folfox4 chemotherapy regimen

    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.

    Other Name: F4 chemo
  • Other: Placebo

    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.

    Other Name: control
Study Arms  ICMJE
  • Experimental: folfox4 chemotherapy regimen
    details in the "Intervention Description"
    Intervention: Drug: folfox4 chemotherapy regimen
  • Placebo Comparator: Placebo
    details in the "Intervention Description"
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 22, 2016)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02813096
Other Study ID Numbers  ICMJE GuangxiMUJYe
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jiazhou Ye, Guangxi Medical University
Study Sponsor  ICMJE Guangxi Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lequn Li, M.D. Cancer Hospital of Guangxi Medical University
Principal Investigator: Jiazhou Ye, M.D. Cancer Hospital of Guangxi Medical University
PRS Account Guangxi Medical University
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP