Actively Recruiting
Durvalumab With/Without Tremelimumab After Palliative Hypofractionated Radiotherapy for Hepatocellular Carcinoma
Led by Mary Feng, MD · Updated on 2025-12-08
21
Participants Needed
1
Research Sites
390 weeks
Total Duration
On this page
Sponsors
M
Mary Feng, MD
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies how well standard of care hypofractionated radiation therapy followed by durvalumab with or without tremelimumab works in treating patients with hepatocellular cancer (liver cancer) that has spread to other places in the body (advanced) and that is growing, spreading, or getting worse (progressing). In some patients, cancer cells and immune cells start to express signals that stop the body's immune system from killing the cancer. New drugs being developed, such as durvalumab and tremelimumab, are designed to target and block these signals and may help increase the immune response to prevent or slow down cancer growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may help the immune system work even better. Giving durvalumab with or without tremelimumab after radiation therapy may work better than radiation therapy alone in treating patients with liver cancer.
CONDITIONS
Official Title
Durvalumab With/Without Tremelimumab After Palliative Hypofractionated Radiotherapy for Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or radiographically diagnosed advanced hepatocellular carcinoma with or without prior PD-(L)1 checkpoint inhibitor therapy
- At least one measurable tumor by RECIST 1.1 criteria that has not been previously treated with radiation or local therapy
- Clinical indication for radiation therapy to any tumor site
- Child Pugh score of A, B7, or B8 with other liver function criteria met
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Receiving appropriate antiviral therapy for hepatitis B with HBV DNA less than 2000 IU/mL
- Adequate organ function including specified blood counts, liver tests, kidney function, and coagulation parameters
- No contraindications to immune checkpoint inhibitor therapy or radiation therapy
- Age 18 years or older
- Life expectancy of at least 12 weeks
- Body weight greater than 30 kg (66.1 pounds)
- Women must be post-menopausal or have a negative pregnancy test if pre-menopausal, with specific criteria based on age
- Agreement to use adequate contraception during and after study participation as specified
- Ability and willingness to comply with study procedures and provide informed consent
You will not qualify if you...
- Prior radiation therapy to tumor sites that may compromise safety of additional treatments
- Prior radiation to more than 30% of bone marrow or wide field within 4 weeks before study treatment
- Previous treatment with CTLA-4 or PD-L1 inhibitors
- History of allogenic organ transplantation
- Severe immune-related adverse events from prior PD-1 inhibitor therapy or ongoing unresolved adverse events
- Major surgery, liver-directed therapy, or other anticancer treatments within 4 weeks before enrollment
- Unresolved toxicities from prior cancer therapies of grade 2 or higher except specified exceptions
- Concurrent enrollment in other interventional clinical studies except follow-up periods
- Active or prior autoimmune or inflammatory disorders except certain controlled conditions
- Uncontrolled illnesses or infections that could affect study participation
- History of other primary cancers unless meeting specific remission criteria
- History of leptomeningeal carcinomatosis or active primary immunodeficiency
- Known HIV infection
- Recent use of immunosuppressive medications except specified exceptions
- Receipt of live attenuated vaccine within 30 days before first dose
- Pregnancy or breastfeeding or unwillingness to use effective birth control
- Known allergies to study drugs
- Prior participation in durvalumab or tremelimumab clinical trials
- Involvement in planning or conduct of this study
- Any condition making the participant unsuitable for the trial as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
L
Luchia Andemicael
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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