Hepatocellular carcinoma Hepatocellular carcinoma
Conditions
Interventions
Durvalumab monotherapy
Sponsors
Terashima Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of treatment-related severe adverse events occurred within 6 months after the treatment starts | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactTomoyuki Satake
National Cancer Center Hospital East
Outcome results
None listed