NCT05194293

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

Neoadjuvant Regorafenib Plus Durvalumab (MEDI4736) in Patients With High-Risk Hepatocellular Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Academic and Community Cancer Research United · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stage IB Hepatocellular Carcinoma AJCC v8
• Stage II Hepatocellular Carcinoma AJCC v8
• Stage III Hepatocellular Carcinoma AJCC v8
• Stage IIIA Hepatocellular Carcinoma AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	Durvalumab	Given IV
DRUG	Regorafenib	Given PO

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-12-05
• Completion: 2028-12-05
• First posted: 2022-01-18
• Last updated: 2025-09-04

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study