RecruitingPhase 2

Durvalumab With/Without Tremelimumab After Palliative Hypofractionated Radiotherapy for Hepatocellular Carcinoma

United States21 participantsStarted 2022-02-04

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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.
✓. Clinical indication for RT to any site (e.g. painful primary or metastatic tumor, local complication risk such as impending biliary or vascular obstruction).
✓. Child Pugh score of A, B7, or B8 provided other liver function criteria are met.
✓. Eastern Cooperative Oncology Group (ECOG) 0 or 1
✓. 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.
✓. Adequate organ function as defined below:
✓. No contraindication to immune checkpoint inhibitor immunotherapy.

Exclusion criteria

What they're measuring

Objective response rate (ORR)

Timeframe: Up to 2 years

Trial details

NCT IDNCT04430452

SponsorMary Feng, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-31

Contact for this trial

Luchia Andemicael

(415) 530-9814 Luchia.Andemicael@ucsf.edu

View on ClinicalTrials.gov More Advanced Hepatocellular Carcinoma trials