NIPH Clinical Trials Search

Phase II study of durvalumab monotherapy for patients with unresectable hepatocellular carcinoma and Child-Pugh B

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Hepatocellular carcinoma
Date of first enrollment	19/02/2026
Target sample size	24
Countries of recruitment
Study type	Interventional
Intervention(s)	Durvalumab monotherapy

Outcome(s)

Primary Outcome	The frequency of treatment-related severe adverse events occurred within 6 months after the treatment starts
Secondary Outcome	Liver-related adverse events, immune-related adverse events, severe adverse events, adverse events, trends of Child-Pugh scores and ALBI scores, objective response rate, progression-free survival, overall survival

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Clinically diagnosed as hepatocellular carcinoma 2) Unsuitable for local therapy 3) Child-Pugh score of 7 or 8 4) 20 years old or older 5) ECOG Performance status of 0, 1, or 2 6) Presence of measurable lesion 7) No prior systemic therapy 8) Preserved major organ function 9) Written informed consent
Exclude criteria	1) Active double cancer 2) Receiving any combination of chemotherapy, investigational drugs, and biologic or hormonal therapy for the treatment of cancer 3) With previous radiotherapy 4) Active infection 5) Fever of 38 degrees celsius or higher 6) Active autoimmune or inflammatory disease or a confirmed history of such disease 7) Taking immunosuppressive therapy 8) Taking antiplatelet or anticoagulant medication 9) Complicated by one or more of interstitial pneumonia, pulmonary fibrosis, or severe emphysema 10) Unhealed fistulas, ulcerative lesions, and active bleeding 11) Bleeding risk of esophageal and gastric varices 12) Metastases to central nervous system 13) Moderate or severe ascites and/or pleural effusion 14) Severe complication 15) Poorly controlled diabetes 16) Pregnant or lactating women, or women of childbearing potential or her partner 17) Mental disorder 18) Patients who investigator regards as inappropriate for candidate