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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Hepatocellular | Drug: folfox4 chemotherapy regimen Other: Placebo | Not Applicable |
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"
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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"
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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 |
- early recurrence [ Time Frame: from date of randomization until the first document recurrence from any cause, whichever came first, assessed up to 2 years ]
- overall survival [ Time Frame: from date of randomization until the date of death from any cause, whichever came first, assessed up to 5 years ]

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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 |
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

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
Contact: Jiazhou Ye, M.D. | +86 13367719078 | nnsz20013@163.com | |
Contact: Lequn Li, M.D. | +86 15077679083 | Lequn_li001@163.com |
Study Chair: | Lequn Li, M.D. | Cancer Hospital of Guangxi Medical University | |
Principal Investigator: | Jiazhou Ye, M.D. | Cancer Hospital of Guangxi Medical University |
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 |
HCC PVTT Folofox4 Early Recurrence |
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 |