NCT06999707

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

Photon Radiotherapy Combined With Tremelimumab and Durvalumab for BCLC Stage B and C Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HCC - Hepatocellular Carcinoma
• Tremelimumab
• Durvalumab
• Radiotherapy

Interventions

Type	Name	Description
RADIATION	Photon radiotherapy	* 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
DRUG	Tremelimumab	Tremelimumab 300 mg will be administered as an IV infusion for one dose
DRUG	Durvalumab	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.

Timeline

• Start date: 2025-05-22
• Primary completion: 2030-05-31
• Completion: 2033-05-31
• First posted: 2025-05-31
• Last updated: 2025-06-05

Locations

1 site across 1 country: Taiwan