Hepatocellular Cancer
Conditions
Brief summary
This study is a survey in Japan of Cabozantinib tablets used to treat Japanese people with a type of liver cancer called hepatocellular carcinoma. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects from Cabozantinib. During the study, participants with hepatocellular carcinoma will take Cabozantinib tablets according to their clinic's standard practice. The study doctors will check for side effects from Cabozantinib for 12 months.
Interventions
DRUGCabozantinib
Cabozantinib tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Participants with unresectable hepatocellular carcinoma that has progressed after cancer chemotherapy (Regardless of previous treatment history)
Exclusion criteria
Participants who has a history of hypersensitivity to any component of cabozantinib.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Grade 3 or higher Adverse Events | Up to 12 months | Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. |
| Number of Participants with Adverse Events Related to Hepatic Failure, Hepatic Dysfunction, and Pancreatitis | Up to 12 months | An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
| Number of Participants with Serious Adverse Events | Up to 12 months | A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. |
| Number of Participants with Adverse Events Leading to Permanent Treatment Discontinuation with Cabozantinib Tablets | Up to 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve or Maintain Any Best Response Category Assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Up to 12 months | Best response will be assessed with reference to the excerpts from Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Best response is defined as the level of best response in assessment with complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD) and not evaluable (NE) during the observational period. |
| Percentage of Participants Who Achieve or Maintain Any Best Response Category Assessed by Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) | Up to 12 months | Best response will be assessed with reference to the excerpts from Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST). Best response is defined as the level of best response in assessment with CR, PR, PD, SD and NE during the observational period. |
| Disease Control Rate (DCR) | Up to 12 months | DCR was defined as the percentage of participants whose best overall response is CR, PR or SD, per RECIST 1.1. CR was defined as disappearance of all target lesions; PR was defined as at least a 30% decrease in the sum of diameter (SoD) of target lesions, taking as a reference the baseline SoD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Overall Survival (OS) | Up to 12 months | OS is defined as time from the first day of study drug administration to death due to any cause. |
Countries
Japan
Outcome results
None listed