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

Sponsor
Chang Gung Memorial Hospital
Study ID
NCT06999707
Phase
PHASE2
Status
Recruiting
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Conditions

  • Durvalumab
  • HCC - Hepatocellular Carcinoma
  • Radiotherapy
  • Tremelimumab

Eligibility Criteria

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

Interventions

  • Photon radiotherapy — RADIATION
    * 39.6-72.6 Gy in 22 fractions for tumors ≤1 cm from hepatic hilum, bowel, and heart. * 30-66 Gy in 10 fractions for tumors \>1 cm from hepatic hilum, bowel, and heart. * 27.5-50 Gy in 5 fractions using stereotactic body radiation therapy (SBRT) techniques
  • Tremelimumab — DRUG
    Tremelimumab 300 mg will be administered as an IV infusion for one dose
  • Durvalumab — DRUG
    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 (the STRIDE regimen) is an approved first-line therapy for unresectable hepatocellular carcinoma (HCC); however, it demonstrates limited efficacy, with an objective response rate (ORR) of only 20.1%. Radiation therapy (RT) is highly effective in controlling localized solid tumors and has become an integral component of the treatment algorithm for unresectable HCC. Preclinical studies have shown that combining RT with PD-L1/PD-1 blockade promotes immunogenic cell death and enhances antigen presentation by dendritic cells, thereby boosting systemic T cell-mediated antitumor responses in mouse models. The addition of CTLA-4 inhibition further enhances antigen cross-priming following RT. Recent retrospective data also indicate that combining RT with immune-oncology agents is associated with improved overall survival and prolonged time to progression compared to RT or immunotherapy alone. However, the clinical benefit and immunologic impact of combining RT with tremelimumab and durvalumab have not yet been evaluated in prospective clinical trials for unresectable HCC. This phase II, single-arm clinical trial aims to assess 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
Jun 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: Photon radiotherapy combined with Tremelimumab and Durvalumab
    Patients undergo photon radiotherapy combined with Tremelimumab and Durvalumab.

Primary Outcome Measure

Progression free survival [ Time Frame: 12 months ]

Central Contacts

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