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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: folfox4 chemotherapy regimen Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : October 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: folfox4 chemotherapy regimen
details in the "Intervention Description"
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

Placebo Comparator: Placebo
details in the "Intervention Description"
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




Primary Outcome Measures :
  1. early recurrence [ Time Frame: from date of randomization until the first document recurrence from any cause, whichever came first, assessed up to 2 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: from date of randomization until the date of death from any cause, whichever came first, assessed up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813096


Contacts
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Contact: Jiazhou Ye, M.D. +86 13367719078 nnsz20013@163.com
Contact: Lequn Li, M.D. +86 15077679083 Lequn_li001@163.com

Sponsors and Collaborators
Guangxi Medical University
Investigators
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Study Chair: Lequn Li, M.D. Cancer Hospital of Guangxi Medical University
Principal Investigator: Jiazhou Ye, M.D. Cancer Hospital of Guangxi Medical University
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Responsible Party: Jiazhou Ye, M.D., Guangxi Medical University
ClinicalTrials.gov Identifier: NCT02813096    
Other Study ID Numbers: GuangxiMUJYe
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jiazhou Ye, Guangxi Medical University:
HCC
PVTT
Folofox4
Early Recurrence
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases