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OncoMatch/Clinical Trials/NCT04430452

Durvalumab With/Without Tremelimumab After Palliative Hypofractionated Radiotherapy for Hepatocellular Carcinoma

Is NCT04430452 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Durvalumab and Tremelimumab for advanced hepatocellular carcinoma.

Phase 2RecruitingMary Feng, MDNCT04430452Data as of May 2026

Treatment: Durvalumab · TremelimumabThis phase II trial studies how well standard of care hypofractionated radiation therapy followed by durvalumab with or without tremelimumab works in treating patients with hepatocellular cancer (liver cancer) that has spread to other places in the body (advanced) and that is growing, spreading, or getting worse (progressing). In some patients, cancer cells and immune cells start to express signals that stop the body's immune system from killing the cancer. New drugs being developed, such as durvalumab and tremelimumab, are designed to target and block these signals and may help increase the immune response to prevent or slow down cancer growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may help the immune system work even better. Giving durvalumab with or without tremelimumab after radiation therapy may work better than radiation therapy alone in treating patients with liver cancer.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Disease stage

Required: Stage III, IIIA, IIIB, IV, IVA, IVB

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: PD-L1 inhibitor (durvalumab)

prior durvalumab excluded

Cannot have received: CTLA-4 inhibitor

Prior treatment with cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) or PD-L1 inhibitor.

Lab requirements

Blood counts

Hemoglobin >= 9.0 g/dL; Absolute neutrophil count >= 1,200/mcL; Platelet count >= 60,000/mcL

Kidney function

Creatinine clearance > 30 mL/min by Cockcroft Gault formula

Liver function

Child Pugh score of A, B7, or B8 provided other liver function criteria are met; Serum bilirubin <= 1.5 x institutional ULN (except Gilbert's syndrome); AST <= 2.5 x ULN unless liver metastases present (then <= 5 x ULN); INR < 1.5

Child Pugh score of A, B7, or B8 provided other liver function criteria are met. Hemoglobin >= 9.0 g/dL Absolute neutrophil count >= 1,200/mcL Platelet count >= 60,000/mcL Serum bilirubin <= 1.5 x institutional upper limit of normal. This will not apply to patients with confirmed Gilbert's syndrome ... AST <= 2.5 x institutional upper limit of normal unless liver metastases are present in which case it can be <= 5 x upper limit of normal (ULN) INR < 1.5 Creatinine clearance > 30 mL/min by Cockcroft Gault formula.

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

US trial sites

  • University of California, San Francisco · San Francisco, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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