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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 (Jun 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 Jun 2026Location: Germany

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

Treatments studied

Immunotherapy

TremelimumabDurvalumab

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.

Frequently asked questions

Is NCT04522544 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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