![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
![]() |
Name | UMIN ID |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000046634 |
Receipt No. | R000053192 |
Scientific Title | Resection of initially unresectable hepatocellular carcinoma with atezolizumab plus bevacizumab Additional study: Identification of biomarkers for predicting therapeutic effects and adverse events |
Date of disclosure of the study information | 2022/01/15 |
Last modified on | 2022/01/13 |
Basic information | ||
Public title | Resection of initially unresectable hepatocellular carcinoma with atezolizumab plus bevacizumab
Additional study: Identification of biomarkers for predicting therapeutic effects and adverse events |
|
Acronym | RACB additional study
|
|
Scientific Title | Resection of initially unresectable hepatocellular carcinoma with atezolizumab plus bevacizumab
Additional study: Identification of biomarkers for predicting therapeutic effects and adverse events |
|
Scientific Title:Acronym | RACB additional study
|
|
Region |
|
Condition | |||
Condition | Hepatocellular Carcinoma
|
||
Classification by specialty |
|
||
Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Identification of the biomarkers for atezolizumab and bevasizumab in patients with unresectable HCC |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Serum cytokine, PD-L1, PD-1, CTLA-4, Immunological evaluation of surgical specimens |
Key secondary outcomes | Therapeutic effect on the imaging study, Resectability, Progression-free survival, Overall survival, Adverse event, immune-related Adverse Events (irAE) |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
Interventions/Control_2 | |
Interventions/Control_3 | |
Interventions/Control_4 | |
Interventions/Control_5 | |
Interventions/Control_6 | |
Interventions/Control_7 | |
Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1. Diagnosed with hepatocellular carcinoma and no prior medical therapy (sorafenib, lenvatinib and immunotherapy) for hepatocellular carcinoma
2.Have at least one target lesion based on RECISTver1.1 criteria 3.Age 20 years or older 4.Eastern Cooperative Oncology Group Performance Status (PS) 0-1 5.Adequate organ function If more than one test result is present within the study period, the most recent one to enrollment should be employed, and no blood transfusion and administration of hematopoietic factor products have been performed within 30 days before the test day for measurement prior to enrollment. WBC >=3000/mm3, neutrophil count >=1500/mm3, Hb >=8.5g/dL, platelet count >=60,000/mm3, total bilirubin <=3.0 mg/dL, serum albumin >=2.8g/dL, AST (GOT), ALT (GPT) <=5 times the upper limit of each medical institution (excluding cases associated with cancer) Serum creatinine <=1.5 times the upper limit of each medical institution Urine protein<= 2+ Urine protein/creatinine ratio <2.0 at any time when urine protein is >=3+ (urine protein < 2.0g in case of 24-hour urine collection). 6.Child Pugh score of 5-6 within 14 days prior to enrollment 7.No other active malignancies 8.A patient's written informed consent (IC) has been obtained after sufficient explanation of study given to the patient. 9. Hepatocellular carcinoma tumor conditions are classified as A, B, C, D, or E. *1 Unresectable hepatocellular carcinoma. |
|||
Key exclusion criteria | 1. Currently receiving oral or parenteral anticoagulants or thrombolytics within 10 days prior to enrollment.
2. Have untreated or not adequately treated esophageal varices at high risk of bleeding, or a history of bleeding due to esophageal varices within 180 days prior to enrollment. 3. Had thrombosis and/or embolism within 180 days before enrollment. 4. Has undergone major surgical procedures within 28 days before enrollment. 5. Has received systemic immunostimulatory agents within 180 days prior to enrollment. 6. Has received systemic immunosuppressants within 14 days before enrollment. 7.History and complications of autoimmune disease within 180 days prior to enrollment 8. History of active double cancer or malignancy. 9. Currently participating in another study of unapproved drugs or a study requiring intervention. 10.Critical cardiovascular disease, unstable arrhythmia or unstable angina in the 90 days prior to enrollment. 11.Pregnant, breastfeeding, positive in pregnancy test, women and men unwilling to contraceptive during the study period. 12. Has clinically uncontrolled pleural effusion, pericardial effusion or ascites. 13. Has complications of hepatic encephalopathy 14. Uncontrollable hypertension, severe infection, hemodialysis 15. Has a history of serious allergic or anaphylactic reactions to chimeric antibody, humanized antibody, or fusion protein. 16.Hypersensitivity to either Chinese hamster ovary cell-derived products or components of atezolizumab or bevacizumab products. 17.Has a history of hemorrhagic disease, gastrointestinal hemorrhage or active hemoptysis. 18. Difficult to ingest medication 19.HIV-positive 20. Active pulmonary fibrosis or interstitial pneumonia 21.Has received blood transfusions or G-CSF products within 14 days prior to enrollment 22. The attending physician judges that the patient is not suitable for participating in the study. |
|||
Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | National Center for Global Health and Medicine | ||||||
Division name | Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery | ||||||
Zip code | 162-8655 | ||||||
Address | 1-21-1, Toyama, Shinjuku-ku, Tokyo | ||||||
TEL | 03-3202-7181 | ||||||
kyito@hosp.ncgm.go.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | National Center for Global Health and Medicine | ||||||
Division name | Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery | ||||||
Zip code | 162-8655 | ||||||
Address | 1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan | ||||||
TEL | 03-3202-7181 | ||||||
Homepage URL | |||||||
kyito@hosp.ncgm.go.jp |
Sponsor | |
Institute | National Center for Global Health and Medicine |
Institute | |
Department |
Funding Source | |
Organization | National Center for Global Health and Medicine |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | National Center for Global Health and Medicine |
Address | 1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan |
Tel | 03-3202-7181 |
kenkyu-shinsa@hosp.ncgm.go.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
|
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | 1. Cytokine measurement and imaging will be performed in patients with hepatocellular carcinoma, before, 6 weeks, and 12 weeks after the start of the therapy.
2. Preoperative and postoperative cytokine measurements will be performed. 3. The relationship between biomarkers and prognosis and adverse events will be evaluated. |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053192 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |