Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-04 @ 8:18 AM
Study NCT ID:
NCT04204850
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2019-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cabozantinib to Treat Recurrent Liver Cancer Post Transplant
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
A Phase II Trial of Cabozantinib in the Treatment of Recurrent Hepatocellular Carcinoma Post Liver Transplant
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 2 study that will assess the investigational drug, cabozantinib, in patients with liver cancer (specifically hepatocellular carcinoma) and who had received a liver transplant as a part of curative care, but the cancer has come back (recurred). The purpose of this study is to see how useful cabozantinib is in controlling the disease of these patients.
Cabozantinib blocks the function of various proteins found on the surface of the body's cells (called receptor tyrosine kinases) that are important in the development of cancer tumors.
All participants will receive cabozantinib until they are no longer receiving benefit from the study drug or they experience an intolerable side effect.
Cabozantinib blocks the function of various proteins found on the surface of the body's cells (called receptor tyrosine kinases) that are important in the development of cancer tumors.
All participants will receive cabozantinib until they are no longer receiving benefit from the study drug or they experience an intolerable side effect.
Detailed Description:
The study has three main parts:
Screening: Participants will have test, procedures, and assessments done for safety and eligibility. Some may be done for research purposes only. Several visits may be needed to complete the screening part of the study.
Study Drug Period: During this part, participants will take the study drug as prescribed by the study doctor. While on the study drug, participants will visit the clinic about once a week for tests, procedures, and assessments for safety, eligibility, and research only purposes.
End of Study Drug Visit and Follow-up: Participants will be asked to make an End of Study Drug visit about 30 days after the last dose of study drugs for safety, eligibility, and research only purposes. After this visit, participants will continue to have follow-up visits about every 8 weeks. If participants are experiencing side effects, they will be followed weekly for about 4 weeks, then monthly until resolution or stabilization.
Screening: Participants will have test, procedures, and assessments done for safety and eligibility. Some may be done for research purposes only. Several visits may be needed to complete the screening part of the study.
Study Drug Period: During this part, participants will take the study drug as prescribed by the study doctor. While on the study drug, participants will visit the clinic about once a week for tests, procedures, and assessments for safety, eligibility, and research only purposes.
End of Study Drug Visit and Follow-up: Participants will be asked to make an End of Study Drug visit about 30 days after the last dose of study drugs for safety, eligibility, and research only purposes. After this visit, participants will continue to have follow-up visits about every 8 weeks. If participants are experiencing side effects, they will be followed weekly for about 4 weeks, then monthly until resolution or stabilization.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CAPCR 19-6312 | OTHER | University Health Network | View |