Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT01539018
Status:
TERMINATED
Last Update Posted:
2015-08-05
First Post:
2012-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sorafenib Plus Tegafur-uracil (UFT) Versus Sorafenib as First Line Systemic Treatment for Patients With Advanced Stage HCC, Unresectable & Not Eligible for Local Ablation and/or TACE
Sponsor:
Egyptian Society of Liver Cancer
Organization:
Study Overview
Official Title:
A Phase II Trial of Sorafenib Plus Tegafur-uracil (UFT) vs. Sorafenib as First Line Systemic Treatment for Patients With Advanced Stage HCC, Unresectable & Not Eligible for Local Ablation &/or TACE
Status:
TERMINATED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
After interim results data showed no evidence of a difference between both groups
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
* Unlike the Asian and western regions, The vast majority of the Egyptian/Arabic Hepatocellular Carcinoma (HCC) patients are hepatitis C virus (HCV) associated.
* According to the SHARP study subgroup analysis, it seems that HCV associated HCC patients derive the max benefit of Sorafenib, the absolute gain between the Sorafenib arm \& the placebo in m OS = 7 months, HR=0.58 (95% CI: 0.37-0.91).
* In spite of improvement in terms of overall survival (OS) and time to progression (TTP), in all studies where Sorafenib was compared to placebo, the Sorafenib arm was not accompanied by a significant volumetric reduction, and this may explains the lack of any symptomatic improvement (time to symptomatic progression (TTSP) almost identical)
* Reviewing the chemotherapy outcome, although there is no convincing evidence in survival benefit to patients with advanced HCC, however true shrinkage (reduction in tumor size), has been consistently reported although the magnitude of response is lacking consistency.
This indicates the need for coupling Sorafenib to a chemotherapeutic agent but:
* For patients with Hepatocellular Carcinoma, the toxicity profile of any chemotherapeutic agent of choice to be added to Sorafenib should be take in consideration
* The agent to be added to Sorafenib should be effective in terms of Tumor Shrinkage \& with minimal toxicity regarding:
* Cardio-toxicity
* HFSR
* Diarrhea
* Hepato-toxicity
* Bone marrow suppression (although not relevant to the toxicity profile of Sorafenib, yet the HCC patients may have HCV related thrombocytopenia and variable degree of hypersplenism related pancytopenia)
Circulatory Overload (Hypertension) Why Tegafur-uracil (UFT)?
* Efficacy: For UFT, although the efficacy data in HCC are not as extensive as Doxorubicin, however in one phase II study UFT could improve survival when compared with conservative management.
* UFT Toxicity Profile:
In a phase III trial to asses the compare Efficacy \& Safety of UFT with that of 5 FU in treatment of m CRC, Hematological toxicities were minimal (0% Grade ¾ leukopenia, neutropenia, febrile neutropenia, thrombocytopenia \& was 3% for anemia), while the most commonly seen SE was grade I \& II Diarrhea
•Accordingly UFT may be considered as a potential partner to Sorafenib in patients with advanced HCC.
* According to the SHARP study subgroup analysis, it seems that HCV associated HCC patients derive the max benefit of Sorafenib, the absolute gain between the Sorafenib arm \& the placebo in m OS = 7 months, HR=0.58 (95% CI: 0.37-0.91).
* In spite of improvement in terms of overall survival (OS) and time to progression (TTP), in all studies where Sorafenib was compared to placebo, the Sorafenib arm was not accompanied by a significant volumetric reduction, and this may explains the lack of any symptomatic improvement (time to symptomatic progression (TTSP) almost identical)
* Reviewing the chemotherapy outcome, although there is no convincing evidence in survival benefit to patients with advanced HCC, however true shrinkage (reduction in tumor size), has been consistently reported although the magnitude of response is lacking consistency.
This indicates the need for coupling Sorafenib to a chemotherapeutic agent but:
* For patients with Hepatocellular Carcinoma, the toxicity profile of any chemotherapeutic agent of choice to be added to Sorafenib should be take in consideration
* The agent to be added to Sorafenib should be effective in terms of Tumor Shrinkage \& with minimal toxicity regarding:
* Cardio-toxicity
* HFSR
* Diarrhea
* Hepato-toxicity
* Bone marrow suppression (although not relevant to the toxicity profile of Sorafenib, yet the HCC patients may have HCV related thrombocytopenia and variable degree of hypersplenism related pancytopenia)
Circulatory Overload (Hypertension) Why Tegafur-uracil (UFT)?
* Efficacy: For UFT, although the efficacy data in HCC are not as extensive as Doxorubicin, however in one phase II study UFT could improve survival when compared with conservative management.
* UFT Toxicity Profile:
In a phase III trial to asses the compare Efficacy \& Safety of UFT with that of 5 FU in treatment of m CRC, Hematological toxicities were minimal (0% Grade ¾ leukopenia, neutropenia, febrile neutropenia, thrombocytopenia \& was 3% for anemia), while the most commonly seen SE was grade I \& II Diarrhea
•Accordingly UFT may be considered as a potential partner to Sorafenib in patients with advanced HCC.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: