Unique ID issued by UMIN | UMIN000047758 |
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Receipt number | R000054447 |
Scientific Title | Multicenter study for biomarker on therapeutic effect and safety of Atezolizumab + Bevacizumab in patients with unresectable hepatocellular carcinoma |
Date of disclosure of the study information | 2022/05/16 |
Last modified on | 2023/11/15 19:16:47 |
Study on biomarkers for the effect and safety of the treatment with Atezolizumab + Bevacizumab for liver cancer
Study on biomarkers for liver cancer
Multicenter study for biomarker on therapeutic effect and safety of Atezolizumab + Bevacizumab in patients with unresectable hepatocellular carcinoma
Study on biomarkers in treatment with Atezolizumab + Bevacizumab for hepatocellular carcinoma
Japan |
unresectable advanced hepatocellular carcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
NO
In this study, we will focus on the presence or absence of fever that appears early after the administration of Atezolizumab + Bevacizumab in patients with unresectable advanced hepatocellular carcinoma. By examining the changes in blood cytokines and chemokines by the fever after the treatment, we will search for biomarkers related to early treatment efficacy and the development of irAEs, aiming to establish a suitable strategy with Atezolizumab + Bevacizumab treatment for advanced hepatocellular carcinoma.
Safety
Exploratory
Not applicable
Investigating the biomarkers, including cytokine and chemokine at pretreatment, 1,3,6 week after treatment, on adverse events, including immune-related liver injury
Investigating the biomarkers, including cytokine and chemokine at pretreatment, 1,3,6 week after treatment, on the therapeutic effects and prognosis
Observational
20 | years-old | < |
Not applicable |
Male and Female
Clinically diagnosed as HCC
No indication for local treatment such as liver resection, liver transplantation, or radiofrequency ablation
Having a treatable liver function
Performance status of 0-2 on ECOG
Age is 20 years or older.
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.
91
1st name | Masatoshi |
Middle name | |
Last name | Ishigami |
Nagoya University Graduate School of Medicine
Gastroenterology and Hepatology
466-8560
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan.
0527442169
masaishi@med.nagoya-u.ac.jp
1st name | Takanori |
Middle name | |
Last name | Ito |
Nagoya University Hospital
Gastroenterology and Hepatology
466-8560
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan.
0527442169
tahkun56@med.nagoya-u.ac.jp
Nagoya University Graduate School of Medicine
Chugai Pharmaceutical Co., Ltd.
Profit organization
Ogaki Municipal Hospital
Kariya Toyota general hospital
Tosei General Hospital
Toyohashi Municipal Hospital
Fujita Health University
National Center for Global Health and Medicine
Nagoya University Graduate School of Medicine
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560, Japan.
0527442423
tahkun56@med.nagoya-u.ac.jp
NO
2022 | Year | 05 | Month | 16 | Day |
Unpublished
99
No longer recruiting
2022 | Year | 05 | Month | 06 | Day |
2022 | Year | 03 | Month | 24 | Day |
2022 | Year | 05 | Month | 06 | Day |
2024 | Year | 12 | Month | 31 | Day |
not applicable
2022 | Year | 05 | Month | 14 | Day |
2023 | Year | 11 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054447
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