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

• ClinicalTrials.gov Identifier: NCT02813096
• Recruitment Status: Unknown
• First Posted: June 24, 2016
• Last Update Posted: October 25, 2016
• Sponsor: Guangxi Medical University
• Information provided by (Responsible Party): Jiazhou Ye, Guangxi Medical University

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

• Study Chair: Lequn Li, M.D.; Cancer Hospital of Guangxi Medical University
• Principal Investigator: Jiazhou Ye, M.D.; Cancer Hospital of Guangxi Medical University

More Information

• Responsible Party: Jiazhou Ye, M.D., Guangxi Medical University
• ClinicalTrials.gov Identifier: NCT02813096
• Other Study ID Numbers: GuangxiMUJYe
• First Posted: June 24, 2016
• 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:

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