Survey of Cabozantinib Tablets Used To Treat People With Hepatocellular Carcinoma

NCT05100082 | Completed

• 2 other identifiers: Cabozantinib-5002jRCT2031210403
• Study Type: observational
• Target: 263
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

• 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

• Disease Control Rate (DCR)

  Up to 12 months

• Overall Survival (OS)

  Up to 12 months

Study Arms (1)

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

Interventions

Cabozantinib DRUG

Cabozantinib tablets

Also known as: Cabometyx tablets

Cabozantinib 60 mg

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Participants with unresectable hepatocellular carcinoma that has progressed after cancer chemotherapy (Regardless of previous treatment history)

You may not qualify if:

• Participants who has a history of hypersensitivity to any component of cabozantinib.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda Selected Site

Tokyo, Japan

Location

Related 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.

MeSH Terms

Conditions

Liver Neoplasms

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: October 29, 2021
• Study Start: November 17, 2021
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

JP (1)