Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-31 @ 8:27 AM
Study NCT ID:
NCT05117957
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2022-10-24
First Post:
2021-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Sorafenib in Previously Treated Advanced Hepatocellular Carcinoma: SOPT Study
Sponsor:
Bo Hyun Kim
Organization:
Study Overview
Official Title:
Efficacy and Safety of Sorafenib in Previously Treated Advanced Hepatocellular Carcinoma: SOPT Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2022-10
Last Known Status:
None
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:
To investigate the efficacy and safety of sorafenib administered as later lines of treatment in patients with advanced HCC.
Detailed Description:
Sorafenib (Soranib Tablet) will be administered orally at a dose of 600mg daily without food for patients who have been treated with prior systemic therapy for advanced HCC. The study drug is continued until disease progression, unacceptable toxicity, withdrawal of consent, or study closure.
Response to sorafenib should be assessed at least every 8 weeks (± 7 days) by either CT scan or MRI.
After the treatment phase, subjects will undergo follow up for survival and the use of other anticancer treatments and/or therapies every 12 weeks (± 7 days) from the last dose and the survival follow up will be performed for at least 12 months after the enrollment of the last subject.
Response to sorafenib should be assessed at least every 8 weeks (± 7 days) by either CT scan or MRI.
After the treatment phase, subjects will undergo follow up for survival and the use of other anticancer treatments and/or therapies every 12 weeks (± 7 days) from the last dose and the survival follow up will be performed for at least 12 months after the enrollment of the last subject.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: