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

Carcinoma, Hepatocellular Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02813096
• Other study ID #: GuangxiMUJYe
• Status: Not yet recruiting
• Phase: N/A
• First received: June 16, 2016
• Last updated: October 21, 2016
• Start date: October 2016
• Est. completion date: July 2018

Study information

• Verified date: October 2016
• Source: Guangxi Medical University
• Contact: Jiazhou Ye, M.D.
• Phone: +86 13367719078
• Email: nnsz20013[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangxi Zhuang Autonomous Region
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Recurrence

Intervention

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:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early recurrence		from date of randomization until the first document recurrence from any cause, whichever came first, assessed up to 2 years	No
Secondary	overall survival		from date of randomization until the date of death from any cause, whichever came first, assessed up to 5 years	No