Proton Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC (NCT06999694) | Clinical Trial Compass
RecruitingPhase 2
Proton Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC
Taiwan45 participantsStarted 2025-05-22
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants must have diagnosis of HCC that is deemed unsuitable for surgical resection or transplant. Participants may have multiple lesions with a total maximal tumor dimension of \< 20 cm, and no one lesion \> 15 cm. Diagnosis should be confirmed by at least 1 criterion listed below:
✓. Age ≥18 years at the time of signing informed consent document.
✓. ECOG performance status 0-1.
✓. Barcelona Clinic Liver Cancer (BCLC) stages Intermediate (B) or Advanced (C).
✓. Child-Pugh score 5-6 liver function within 28 days of study registration.
✓. Documented virology status of hepatitis B virus (HBV), as confirmed by screening HBV serology test.
✓. Documented virology status of hepatitis C virus (HCV), as confirmed by screening HCV serology test.
✓. Ability to understand and the willingness to sign a written informed consent document