OncoMatch/Clinical Trials/NCT06999694
Proton Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC
Is NCT06999694 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 (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.
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: to the region of the liver that would result in overlap of radiation therapy 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
Child-Pugh score 5-6 liver function within 28 days of study registration; Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1,000/mm3; Platelet count ≥ 50,000/μL; Total bilirubin < 2.5 mg/dL; Serum albumin >2.8 g/dL; ALT and AST ≤ 3 × 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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