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Completed

NCT Number: NCT05100082

Survey of Cabozantinib Tablets Used To Treat People With 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.

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Key information

Conditions

Hepatocellular Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda Selected Site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cabozantinib

Drug

Cabozantinib tablets

Other names: Cabometyx tablets

Primary outcomes

  1. Number of Participants with Adverse Events Related to Hepatic Failure, Hepatic Dysfunction, and Pancreatitis

    Time frame: 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.

  2. Number of Participants with Serious Adverse Events

    Time frame: 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.

  3. Number of Participants with Adverse Events Leading to Permanent Treatment Discontinuation with Cabozantinib Tablets

    Time frame: Up to 12 months

  4. Number of Participants with Grade 3 or higher Adverse Events

    Time frame: Up to 12 months

    Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Secondary outcomes

  1. Percentage of Participants Who Achieve or Maintain Any Best Response Category Assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    Time frame: 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.

  2. Percentage of Participants Who Achieve or Maintain Any Best Response Category Assessed by Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST)

    Time frame: 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.

  3. Disease Control Rate (DCR)

    Time frame: 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.

  4. Overall Survival (OS)

    Time frame: Up to 12 months

    OS is defined as time from the first day of study drug administration to death due to any cause.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Special Drug Use Surveillance for Cabometyx Tablets "Hepatocellular Carcinoma"

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2021
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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