Proton Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC
Sponsor: Chang Gung Memorial Hospital • ClinicalTrials.gov ID: NCT06999694
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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.
Interventions
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Proton radiotherapy
(Radiation)
* 72.6 CGE in 22 fractions for tumors ≤1 cm from the hepatic hilum, bowel, and heart. * 66 CGE in 10 fractions for tumors \>1 cm from the hepatic hilum, bowel, and heart.
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Tremelimumab
(Drug)
Tremelimumab 300 mg will be administered as an IV infusion for one dose
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Durvalumab
(Drug)
Durvalumab 1500 mg will be administered as an IV infusion every 4 weeks. Treatment Duration Guidelines: * Complete Response (CR): Patients who achieve a CR within one year of treatment will continue durvalumab for a total duration of two years. * Partial Response (PR): Patients who achieve a PR should continue durvalumab until achieving CR, disease progression (PD), or for a total duration of two years. * Stable Disease (SD): Patients with SD will receive duvalumab for a total of 6 doses.
Eligibility criteria
Conditions
Locations
- Chang Gung Memorial Hospital at Linkou — Taoyuan City, Taiwan, Taiwan
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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