Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777851
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2021-02-25
Brief Title:
Regorafenib-pembrolizumab vs TACETARE in Intermediate Stage HCC Beyond Up-to-7
Sponsor:
Translational Research in Oncology
Organization:
Translational Research in Oncology
Study Overview
Official Title:
A Phase III Multicenter Randomized Open-label Trial to Evaluate the Safety and Efficacy of Systemic Therapy With Regorafenib and Pembrolizumab Versus Locoregional Therapy With Transarterial Chemoembolization or Transarterial Radioembolization for the First-line Treatment of Intermediate-stage Hepatocellular Carcinoma With Beyond Up-to-7 Criteria
Status:
RECRUITING
Status Verified Date:
2024-09
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:
REPLACE
Brief Summary:
REPLACE is a phase III multicenter randomized open-label trial to evaluate the efficacy and safety of regorafenib and pembrolizumab Rego-Pembro versus transarterial chemoembolization TACE or transarterial radioembolization TARE for the first-line treatment of hepatocellular carcinoma HCC or liver cancer Approximately 496 patients in around 80 clinical sites worldwide will be randomized to receive either
Investigational arm Regorafenib in combination with pembrolizumab
Control arm Transarterial chemoembolization TACE or transarterial radioembolization TARE
In both arms patients will receive trial treatment until progressive disease unacceptable toxicity deterioration of patients condition that warrants permanent trial treatment discontinuation or other treatment discontinuation criteria is met After trial treatment discontinuation subsequent treatment will be administered according to the Investigators clinical judgment
Investigational arm Regorafenib in combination with pembrolizumab
Control arm Transarterial chemoembolization TACE or transarterial radioembolization TARE
In both arms patients will receive trial treatment until progressive disease unacceptable toxicity deterioration of patients condition that warrants permanent trial treatment discontinuation or other treatment discontinuation criteria is met After trial treatment discontinuation subsequent treatment will be administered according to the Investigators clinical judgment
Detailed Description:
REPLACE is a phase III multicenter randomized open-label trial to evaluate the efficacy and safety of systemic therapy with Rego-Pembro versus loco-regional therapy with TACE or TARE for the first-line treatment of intermediate-stage HCC with beyond up-to-7 criteria Approximately 496 patients 248 in each arm from approximately 80 sites will be randomized in order to power the trial efficiently to measure a clinically meaningful improvement for the primary endpoint PFS according to mRECIST based on the Investigators assessment
The trial will include patients who have been diagnosed with intermediate-stage HCC by biopsy cytology or diagnostic imaging such as dynamic computed tomography CT or magnetic resonance imaging MRI according to the criteria of the American Association for the Study of Liver Diseases AASLD Patients should have at least one measurable lesion per RECIST 11 disease not amenable to curative treatment but amenable to loco-regional therapy with TACE cTACE or DEB-TACE or TARE ECOG PS 0-1 Child-Pugh class A and beyond up-to-7 criteria
The trial will include the following phases
Screening
Treatment
Follow-up
Randomized patients will receive either
Investigational arm Arm A
-Regorafenib at a dose of 90 mg orally qd on days 1 to 21 of a 4-week cycle
In combination with
-Pembrolizumab 400 mg using a 30-minutes iv infusion on day 1 D1 of a 6-week cycle
Control arm Arm B
-Patients will be treated with TACE or TARE on-demand according to sites standard with the goal of controlling all known liver lesions
In both arms patients will receive trial treatment Rego-Pembro or TACETARE until PD per mRECIST unacceptable toxicity deterioration of patients condition that warrants permanent trial treatment discontinuation or other treatment discontinuation criteria are met
The trial will include patients who have been diagnosed with intermediate-stage HCC by biopsy cytology or diagnostic imaging such as dynamic computed tomography CT or magnetic resonance imaging MRI according to the criteria of the American Association for the Study of Liver Diseases AASLD Patients should have at least one measurable lesion per RECIST 11 disease not amenable to curative treatment but amenable to loco-regional therapy with TACE cTACE or DEB-TACE or TARE ECOG PS 0-1 Child-Pugh class A and beyond up-to-7 criteria
The trial will include the following phases
Screening
Treatment
Follow-up
Randomized patients will receive either
Investigational arm Arm A
-Regorafenib at a dose of 90 mg orally qd on days 1 to 21 of a 4-week cycle
In combination with
-Pembrolizumab 400 mg using a 30-minutes iv infusion on day 1 D1 of a 6-week cycle
Control arm Arm B
-Patients will be treated with TACE or TARE on-demand according to sites standard with the goal of controlling all known liver lesions
In both arms patients will receive trial treatment Rego-Pembro or TACETARE until PD per mRECIST unacceptable toxicity deterioration of patients condition that warrants permanent trial treatment discontinuation or other treatment discontinuation criteria are met
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU CT 2022-501969-42-00 | OTHER | European Medicines Agency EMA | None |