Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04599777
Status:
COMPLETED
Last Update Posted:
2022-10-13
First Post:
2020-10-19
Brief Title:
TACE Combined With Sorafenib and Tislelizumab for Advanced HCC
Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Organization:
Second Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
Transcatheter Arterial Chemoembolization Combined With Sintilimab and Bevacizumab for Advanced Hepatocellular Carcinoma An Open-label Single-arm Single-center Prospective Study
Status:
COMPLETED
Status Verified Date:
2022-02
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:
This study will evaluate the efficacy and safety of transcatheter arterial chemoembolization TACE combined with sorafenib and tislelizumab in patients with advanced hepatocellullar carcinoma HCC
Detailed Description:
This is a Phase II study to evaluate the efficacy and safety of TACE combined with sorafenib and tislelizumab in patients with advanced HCC
30 subjects with advanced HCC Barcelona-Clinic- Liver-Cancer BCLC stage C or China liver cancer staging CNLC IIIa and IIIb will be enrolled in the study
Both sorafenib 400mg PO Bid and tislelizumab 200mg IV q3w will be started at 3-7 days after the first TACE TACE will be repeated if clinically indicated based on the evaluation of follow-up laboratory and imaging examination Sorafenib will last until disease progresses intolerable toxicity withdrawal of informed consent loss of follow-up death or other circumstances that require termination of treatment whichever occurs first Sorafenib administration will be delayed in cases of grade 2 hand-foot syndrome grade 3 hematologic toxicities or grade 3 hypertension After recovery sorafenib will be reintroduced at a reduced dose according the sorafenib dose delay and reduction guidelines Treatment of tislelizumab will last up to 24 months or until disease progresses intolerable toxicity withdrawal of informed consent loss of follow-up death or other circumstances that require termination of treatment whichever occurs first Patients will be allowed to have sorafenib or tislelizumab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity
30 subjects with advanced HCC Barcelona-Clinic- Liver-Cancer BCLC stage C or China liver cancer staging CNLC IIIa and IIIb will be enrolled in the study
Both sorafenib 400mg PO Bid and tislelizumab 200mg IV q3w will be started at 3-7 days after the first TACE TACE will be repeated if clinically indicated based on the evaluation of follow-up laboratory and imaging examination Sorafenib will last until disease progresses intolerable toxicity withdrawal of informed consent loss of follow-up death or other circumstances that require termination of treatment whichever occurs first Sorafenib administration will be delayed in cases of grade 2 hand-foot syndrome grade 3 hematologic toxicities or grade 3 hypertension After recovery sorafenib will be reintroduced at a reduced dose according the sorafenib dose delay and reduction guidelines Treatment of tislelizumab will last up to 24 months or until disease progresses intolerable toxicity withdrawal of informed consent loss of follow-up death or other circumstances that require termination of treatment whichever occurs first Patients will be allowed to have sorafenib or tislelizumab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity
Study Oversight
Has Oversight DMC:
None
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?:
None