Survey of Cabozantinib Tablets Used To Treat People With Hepatocellular Carcinoma

Special Drug Use Surveillance for Cabometyx Tablets "Hepatocellular Carcinoma"

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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Cancer
• Intervention / Treatment: Drug: Cabozantinib

• Study Type: Observational
• Enrollment (Actual): 263

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Takeda Selected Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with unrespectable hepatocellular carcinoma that has progressed after cancer chemotherapy in part of routine medical care.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cabozantinib 60 mg; Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.	Drug: Cabozantinib; Cabozantinib tablets; Other Names: Cabometyx tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events Related to Hepatic Failure, Hepatic Dysfunction, and Pancreatitis	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.	Up to 12 months
Number of Participants with Serious Adverse Events	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.	Up to 12 months
Number of Participants with Adverse Events Leading to Permanent Treatment Discontinuation with Cabozantinib Tablets		Up to 12 months
Number of Participants with Grade 3 or higher Adverse Events	Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieve or Maintain Any Best Response Category Assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)	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.	Up to 12 months
Percentage of Participants Who Achieve or Maintain Any Best Response Category Assessed by Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST)	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.	Up to 12 months
Disease Control Rate (DCR)	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.	Up to 12 months
Overall Survival (OS)	OS is defined as time from the first day of study drug administration to death due to any cause.	Up to 12 months

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Liver Neoplasms; cabozantinib
• Other Study ID Numbers: Cabozantinib-5002; jRCT2031210403 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No