Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer

Active:	Yes
Cancer Type:	Liver Cancer / Hepatoblastoma Unknown Primary	NCT ID:	NCT05194293
Trial Phases:	Phase II	Protocol IDs:	ACCRU-GI-1920 (primary) NCI-2021-12021
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Academic and Community Cancer Research United
NCI Full Details:	http://clinicaltrials.gov/show/NCT05194293

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.