Durvalumab With/Without Tremelimumab After Palliative Hypofractionated Radiotherapy for Hepatocellular Carcinoma
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Mary Feng, MD
You may qualify if…
- ✓ 1. Histologically-diagnosed HCC with progression during or after prior PD-(L)1 checkpoint inhibitor immunotherapy (e.g., nivolumab and/or pembrolizumab or atezolizumab; prior durvalumab excluded), or without prior PD-(L)1 checkpoint inhibitor immunotherapy.
- ✓ a. For patients without prior histologic or cytologic diagnosis, radiographic diagnosis is allowed provided patients meet American Association for the Study of Liver Diseases (AASLD) criteria for radiographic diagnosis.
- ✓ 2. At least 1 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1-measurable tumor present which has not received RT or other local therapy prior to enrollment.
- ✓ 3. Clinical indication for RT to any site (e.g. painful primary or metastatic tumor, local complication risk such as impending biliary or vascular obstruction).
- ✓ 4. Child Pugh score of A, B7, or B8 provided other liver function criteria are met.
- ✓ 5. Eastern Cooperative Oncology Group (ECOG) 0 or 1
- ✓ 6. Appropriate antiviral therapy for hepatitis B virus (HBV) according to institutional standard of care with HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) \< 2000 IU/mL.
- ✓ 7. Adequate organ function as defined below:
You may not qualify if…
- ✕ 1. Prior radiotherapy to tumor sites requiring RT which could compromise safety of additional treatments.
- ✕ 2. Prior radiotherapy to more than 30% of bone marrow or to a wide field within 4 weeks of the first study treatment.
- ✕ 3. Prior treatment with cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) or PD-L1 inhibitor.
- ✕ 4. History of allogenic organ transplantation.
- ✕ 5. On prior PD-1 inhibitor immunotherapy:
- ✕ Any immune-related adverse events with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 grade \>= 3 on any prior immunotherapy or toxicity that led to permanent discontinuation of prior immunotherapy.
- ✕ Any AEs while receiving prior immunotherapy not resolved to grade =\< 1 or resolved to baseline, with the exception of patients with endocrine AE of grade =\< 2, who are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic
- ✕ Required the use of additional immunosuppression other than corticosteroids for the management of an AE, experienced recurrence of a grade \>= 3 AE if previously re-challenged, and currently require maintenance doses of \> 10 mg prednisone or equivalent per day
Where it's recruiting
San Francisco
Source: ClinicalTrials.gov · NCT04430452 · last updated 2025-12-08