UMIN ID: UMIN000047758
Registered date:16/05/2022
Study on biomarkers for the effect and safety of the treatment with Atezolizumab + Bevacizumab for liver cancer
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | unresectable advanced hepatocellular carcinoma |
| Date of first enrollment | 2022/05/06 |
| Target sample size | 91 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Investigating the biomarkers, including cytokine and chemokine at pretreatment, 1,3,6 week after treatment, on adverse events, including immune-related liver injury |
|---|---|
| Secondary Outcome | Investigating the biomarkers, including cytokine and chemokine at pretreatment, 1,3,6 week after treatment, on the therapeutic effects and prognosis |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patients who wish to be excluded from the study. Patients who are pregnant, or lactating, may become pregnant, intend to become pregnant, or who wish to have a baby. Patients with the following serious complications: 1. Cardiovascular abnormalities such as heart failure, angina pectoris, or arrhythmia are difficult to control even after treatment. 2. Myocardial infarction within 6 months of onset 3. Renal failure 4. Active infectious disease except for viral hepatitis 5. Active gastrointestinal bleeding 6. Other active cancer requiring treatment 7. Hepatic encephalopathy or severe mental disorder 8. Severe drug allergy 9. Serious autoimmune disease. Other conditions that the physician deems inappropriate for the safe conduct of this study. |
Related Information
| Primary Sponsor | Nagoya University Graduate School of Medicine |
|---|---|
| Secondary Sponsor | Ogaki Municipal Hospital Kariya Toyota general hospital Tosei General Hospital Toyohashi Municipal Hospital Fujita Health University National Center for Global Health and Medicine |
| Source(s) of Monetary Support | Chugai Pharmaceutical Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Takanori Ito |
| Address | 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan. Japan 466-8560 |
| Telephone | 0527442169 |
| tahkun56@med.nagoya-u.ac.jp | |
| Affiliation | Nagoya University Hospital Gastroenterology and Hepatology |
| scientific contact | |
| Name | Masatoshi Ishigami |
| Address | 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan. Japan |
| Telephone | 0527442169 |
| masaishi@med.nagoya-u.ac.jp | |
| Affiliation | Nagoya University Graduate School of Medicine Gastroenterology and Hepatology |