Ignite Creation Date:
2024-05-06 @ 4:07 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02452853
Status:
UNKNOWN
Last Update Posted:
2015-05-25
First Post:
2015-05-05
Brief Title:
HR Combined With FOLFOX4 for HCC With PVTT
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Hepatic Resection Combined With or Without Oxaliplatin5-Fluorouracil Leucovorin5-FULVFOLFOX4 for Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Status:
UNKNOWN
Status Verified Date:
2015-05
Last Known Status:
ACTIVE_NOT_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 cancer and the third most frequent cause of cancer death worldwide Hepatic resection HR is the conventional curative treatment for HCC In both the European and the United States Proposed Guidelines for HCC HR is recommended only for patients with preserved liver function and with early stage HCC Unfortunately because of tumor multifocality portal vein invasion and underlying advanced cirrhosis only 10 to 30 of HCCs are amenable to such a curative treatment at the time of diagnosis Transarterialchemoembolization TACE has become the most popular palliative treatment for patients with unresectable HCC and it is no longer considered as a contraindication to HCC with portal vein tumor thrombus PVTT Unfortunately the long-term outcomes are generally poor for HCC treated with TACE especially for HCC with PVTT To improve on the results of treatment of HCC with PVTT attempts have been made to perform HR for these patients HCC with PVTT remains a contraindication to liver transplantation because of the high rate of tumor recurrence and because of the severe shortage of donor organs HR remains the only therapeutic option that may still offer a chance of cure With advances in surgical techniques it has become feasible to remove all gross tumors including PVTT which has extended to the main portal vein safely by surgery More HCC with PVTT which previously were considered as unresectable have become resectableRecent studies have even shown favorable long-term survival outcomes of HR in well-selected cases of HCC with PVTT However the recurrence rate after HR for PVTT is still high and the prognosis for patients with HCC with PVTT is very poor Systemic chemotherapy is considered to be one of the main treatments for malignant tumors HCC is known to be highly refractory to conventional systemic chemotherapy because of its heterogeneity and multiple etiologies Before the advent of the molecular-targeted agent sorafenib which has subsequently become the standard of care no standard systemic drug or treatment regimen had shown an obvious survival benefit in HCC Nowadays there is no systemic chemotherapy regimen had been definitively recommended as the standard for treating HCC Clinical activity of several regimens containing oxaliplatin OXA in advanced HCC had been demonstrated in phase II studies In a phase II study of the FOLFOX4 infusional fluorouracil FU leucovorinLV and OXA regimen in Chinese patients with HCC median overall survival OS was 124 months mean time to progression was 20 months and the response rate RR was 182 The safety profile was acceptable Recently the results of a phase Ⅲ randomize study showed that FOLFOX4 served as palliative chemotherapy can induce higher overall survival progression-free survival and response rate comparing to doxorubicin in patients with advanced hepatocellular carcinoma from Asia The safety data was also acceptableSo the investigators hypothesis is that post-surgery FOLFOX4 can reduce high recurrence rate after HR for HCC with PVTT The aim of this open-label single prospective study is to evaluate the efficacy and safety of HR combined with FOLFOX4 systemic chemotherapy for patients with HCC with PVTT
Detailed Description:
None
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