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

NCT02813096 | Unknown DMC

• 1 other identifier: GuangxiMUJYe
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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

Conditions

Carcinoma, Hepatocellular

Keywords

HCC; PVTT; Folofox4; Early Recurrence

Outcome Measures

Primary Outcomes (1)

• early recurrence

  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

  from date of randomization until the date of death from any cause, whichever came first, assessed up to 5 years

Study Arms (2)

folfox4 chemotherapy regimen

EXPERIMENTAL

details in the "Intervention Description"

Drug: folfox4 chemotherapy regimen

Placebo

PLACEBO COMPARATOR

details in the "Intervention Description"

Other: Placebo

Interventions

folfox4 chemotherapy regimen DRUG

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.

Also known as: F4 chemo

folfox4 chemotherapy regimen

Placebo OTHER

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.

Also known as: control

Placebo

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangxi Medical University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lequn Li, M.D.

  Cancer Hospital of Guangxi Medical University

  STUDY CHAIR

• Jiazhou Ye, M.D.

  Cancer Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiazhou Ye, M.D.

CONTACT

+86 13367719078; nnsz20013@163.com

Lequn Li, M.D.

CONTACT

+86 15077679083; Lequn_li001@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 24, 2016
• Study Start: October 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 25, 2016

Record last verified: 2016-10