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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Academic and Community Cancer Research United
Study ID
NCT05194293
Phase
PHASE2
Status
Active Not Recruiting

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — BIOLOGICAL
    Given IV
  • Regorafenib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jul 1, 2023
Status verified
Aug 2025
Primary completion
Dec 5, 2025
Completion
Dec 5, 2028

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (regorafenib, durvalumab)
    Patients receive regorafenib PO QD on days 1-21 and durvalumab 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.

Primary Outcome Measure

Objective response rate (ORR) (unconfirmed) [ Time Frame: At 16 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Cancer CenterBirminghamAlabama35233-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Cancer Center· Birmingham, ALEmory University Hospital/Winship Cancer Institute· Atlanta, GAMedical College of Wisconsin· Milwaukee, WI

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