OncoMatch/Clinical Trials/NCT06999707
Photon Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC
Is NCT06999707 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tremelimumab and Durvalumab for hcc - hepatocellular carcinoma.
Treatment: Tremelimumab · Durvalumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Exception: if not overlapping with planned fields
Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields
Cannot have received: selective internal radiotherapy/hepatic arterial yttrium therapy
Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time
Cannot have received: solid organ transplantation
Prior solid organ transplantation.
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1,000/mm3; Platelet count ≥ 50,000/μL
Kidney function
Serum creatinine ≤ 1.5 mg/dL
Liver function
Child-Pugh score 5-6 liver function within 28 days of study registration; Total bilirubin < 2.5 mg/dL; Serum albumin >2.8 g/dL; ALT and AST ≤ 3 × ULN; Prothrombin time ≤ 6 seconds prolonged
Adequate bone marrow, liver, and renal function within 4 weeks before study registration * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count (ANC) ≥ 1,000/mm3 * Platelet count ≥ 50,000/μL * Total bilirubin < 2.5 mg/dL * Serum albumin >2.8 g/dL * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) * Prothrombin time ≤ 6 seconds prolonged * Serum creatinine ≤ 1.5 mg/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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