Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT05194293
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2021-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer
Sponsor:
Academic and Community Cancer Research United
Organization:
Study Overview
Official Title:
Neoadjuvant Regorafenib Plus Durvalumab (MEDI4736) in Patients With High-Risk Hepatocellular Carcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
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 phase II trial tests whether regorafenib and durvalumab work to shrink tumors in patients with high-risk liver cancer. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving regorafenib and durvalumab may work better in treating patients with high-risk liver cancer.
Detailed Description:
PRIMARY OBJECTIVE:
I. To assess the overall response rate (ORR) at 16 weeks post registration.
SECONDARY OBJECTIVES:
I. To assess the rate of patients who undergo surgery during the course of the study.
II. To assess the safety and tolerability of the combination therapy of regorafenib plus durvalumab.
III. To assess the effect of combination therapy on overall survival. IV. To assess the effect of combination therapy on progression-free survival (PFS) in patients that do not undergo resection.
V. To assess the effect of combination therapy on recurrent-free survival (RFS) in patients that have resection.
VI. To assess the rate of pathologic complete response.
CORRELATIVE RESEARCH OBJECTIVE:
I. Analyze the effect of regorafenib and durvalumab on immune biomarkers in the tumor microenvironment and systemic circulation.
OUTLINE:
Patients receive regorafenib orally (PO) once daily (QD) on days 1-21 and durvalumab intravenously (IV) on day 1. Treatment repeats every 28 days for a maximum of 2 years from registration or until decision to proceed to surgery, disease progression, excessive toxicity, or patient withdrawal.
After completion of study treatment, patients are followed every 90 days for 3 years.
I. To assess the overall response rate (ORR) at 16 weeks post registration.
SECONDARY OBJECTIVES:
I. To assess the rate of patients who undergo surgery during the course of the study.
II. To assess the safety and tolerability of the combination therapy of regorafenib plus durvalumab.
III. To assess the effect of combination therapy on overall survival. IV. To assess the effect of combination therapy on progression-free survival (PFS) in patients that do not undergo resection.
V. To assess the effect of combination therapy on recurrent-free survival (RFS) in patients that have resection.
VI. To assess the rate of pathologic complete response.
CORRELATIVE RESEARCH OBJECTIVE:
I. Analyze the effect of regorafenib and durvalumab on immune biomarkers in the tumor microenvironment and systemic circulation.
OUTLINE:
Patients receive regorafenib orally (PO) once daily (QD) on days 1-21 and durvalumab intravenously (IV) on day 1. Treatment repeats every 28 days for a maximum of 2 years from registration or until decision to proceed to surgery, disease progression, excessive toxicity, or patient withdrawal.
After completion of study treatment, patients are followed every 90 days for 3 years.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-12021 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| ACCRU-GI-1920 | OTHER | Academic and Community Cancer Research United | View | |
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |