Proton Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC

Sponsor
Chang Gung Memorial Hospital
Study ID
NCT06999694
Phase
PHASE2
Status
Recruiting
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Conditions

  • Durvalumab
  • HCC - Hepatocellular Carcinoma
  • Proton Radiotherapy
  • Tremelimumab

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Tremelimumab — DRUG
    Tremelimumab 300 mg will be administered as an IV infusion for one dose
  • 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.

Study Details

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.

Key Dates

Start date
May 22, 2025
Status verified
May 2025
Primary completion
May 31, 2030
Completion
May 31, 2033

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Proton radiotherapy combined with Tremelimumab and Durvalumab
    Patients undergo proton radiotherapy combined with Tremelimumab and Durvalumab.

Primary Outcome Measure

Progression free survival [ Time Frame: 12 months ]

Central Contacts

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