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OncoMatch/Clinical Trials/NCT04522544

Durvalumab and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCC

Is NCT04522544 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tremelimumab and Durvalumab for hepatocellular carcinoma non-resectable.

Phase 2RecruitingInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestNCT04522544Data as of May 2026

Treatment: Tremelimumab · DurvalumabA Phase II study of immunotherapy with Durvalumab (MEDI4736) and Tremelimumab in combination with Y-90 SIRT for intermediate stage HCC

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic anti-cancer therapy

No prior systemic anti-cancer therapy

Cannot have received: radiotherapy

Exception: administered < 4 weeks prior to study entry

radiotherapy administered < 4 weeks prior to study entry

Cannot have received: endocrine therapy

endocrine- or immunotherapy or use of other investigational agents

Cannot have received: immunotherapy

endocrine- or immunotherapy or use of other investigational agents

Cannot have received: investigational agent

Exception: used within 4 weeks prior to the first dose of study treatment

has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

Cannot have received: locoregional therapy

Exception: ongoing or completed < 4 weeks prior to the baseline scan

Locoregional therapies ongoing or completed < 4 weeks prior to the baseline scan

Lab requirements

Blood counts

Hemoglobin ≥ 9.0 g/dL, ANC ≥1.5 (or 1.0) x (> 1500 per mm^3), platelets ≥100 (or 75) x 10^9/L (>75,000 per mm^3)

Kidney function

Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine clearance CL>40 mL/min by Cockcroft-Gault formula or by 24-hour urine collection

Liver function

Child-Pugh A; Serum bilirubin ≤1.5 x institutional ULN; AST (SGOT), ALT (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present, in which case ≤5x ULN; INR ≤ 1.25; Albumin ≥ 31 g/dL

Adequate blood count, liver-enzymes, and renal function: Hemoglobin ≥ 9.0 g/dL, ANC ≥1.5 (or 1.0) x (> 1500 per mm^3), platelets ≥100 (or 75) x 10^9/L (>75,000 per mm^3); Serum bilirubin ≤1.5 x institutional ULN; AST (SGOT), ALT (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present, in which case ≤5x ULN; INR ≤ 1.25. Albumin ≥ 31 g/dL. Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine clearance CL>40 mL/min by Cockcroft-Gault formula or by 24-hour urine collection

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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