Proton Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChang Gung Memorial Hospital
About this trial
Tremelimumab plus durvalumab (STRIDE regimen) is an approved first-line therapy for unresectable hepatocellular carcinoma (HCC), yet it shows limited efficacy with an ORR of only 20.1%. Proton radiotherapy (RT), known for its precision and tissue-sparing advantages, has demonstrated improved survival outcomes and reduced toxicity compared to X-ray RT. Retrospective data suggest that combining proton RT with immune checkpoint inhibitors yields a promising ORR of 61.5%. Preclinical studies further support enhanced antitumor immunity when RT is combined with PD-L1 and CTLA-4 blockade. This phase II, single-arm clinical trial aims to evaluate the safety, efficacy, and immunologic effects of combining proton RT with tremelimumab and durvalumab in patients with unresectable HCC.
Eligibility criteria
Qualifiers
Histologically or cytologically proven diagnosis of HCC.
Typical arterial enhancement and delayed washout on multiphasic CT or MRI.
Age ≥18 years at the time of signing informed consent document.
ECOG performance status 0-1.
Disqualifiers
Prior invasive malignancy unless disease free for a minimum of 2 years
Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields
Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time
Untreated active hepatitis B or hepatitis C
Trial design
Treatments tested in this trial
- Proton radiotherapy
- Tremelimumab
- Durvalumab
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov