Survey of Cabozantinib Tablets Used To Treat People With Hepatocellular Carcinoma

JRCT ID: jRCT2031210403

Registered date:01/11/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 17/11/2021
• Target sample size: 263
• Study type: Observational

Outcome(s)

Primary Outcome

1.Number of Participants with Adverse Events Related to Hepatic Failure, Hepatic Dysfunction, and Pancreatitis
Timeframe: 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
Timeframe: 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
Timeframe: Up to 12 months

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

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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Participants with unresectable hepatocellular carcinoma that has progressed after cancer chemotherapy (Regardless of previous treatment history).
• Exclude criteria: Participants who has a history of hypersensitivity to any component of cabozantinib.

Related Information

• Primary Sponsor: Contact for Clinical Trial Information
• Secondary ID(s): NCT05100082