Ignite Creation Date:
2024-05-06 @ 8:24 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02738697
Status:
UNKNOWN
Last Update Posted:
2016-11-02
First Post:
2016-03-24
Brief Title:
Adjuvant Chemotherapy With FOLFOX in HCC Patients After Resection
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
The Clinical Randomized Trial of Adjuvant Chemotherapy With FOLFOX in HCC Patients at High Risk After Resection
Status:
UNKNOWN
Status Verified Date:
2016-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hepatocellular carcinoma HCC is the sixth most common malignancies worldwide and the second leading cause of cancer-related death Surgical resection is still the main radical approach for HCC but the recurrence rate after hepatectomy is very high which hampers the further improvement of prognosis of HCC patients The conventional risk factors of recurrence including huge tumor multiple lesions vessels invasion and tumor rupture Recently the microvessels invasion MVI has been recognized a novel risk factor of recurrence after hepatectomy The investigators previous study showed that the recurrence rate is more than 50 for the patients with 5cm solitary tumor and MVI The MVI was confirmed as the only independent risk factor for the overall and disease-free survival of HCC patients in multiple variables analysis It is important to reduce the recurrence and prolong the survival of patients after hepatectomy with effective adjuvant therapy Reported at 2014 American Society of Clinical Oncology ASCO annual meeting A phase III randomized double-blind placebo-controlled trial of adjuvant sorafenib after resection or ablation to prevent recurrence of hepatocellular carcinoma STORM trial failed to meet the primary endpoint-recurrence free survival RFS Given the inspiring result of a recent trial which compared with single agent of doxorubicin the oxaliplatin-containing regimens FOLFOX showed significant improvement in OS objective response rate ORR and disease control rate DCR in Asian especially China HCC patients Based on these rationales the investigators design the current prospective randomized clinical trial to evaluate the effect of adjuvant chemotherapy with FOLFOX to prolong the overall survival and reduce the recurrence in HCC patients at high risk 5cm solitary tumor and MVI after resection compared to vigilant follow-up
Detailed Description:
The patients with solitary tumor more than 5cm and microvessels invasion after radical hepatectomy were randomized to receive adjuvant FOLFOX chemotherapy 812 cycles or follow-up The main endpoint overall survival OS disease-free survivalDFS and safety were compared between this two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None