Cabozantinib to Treat Recurrent Liver Cancer Post Transplant
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- STATUS
- Recruiting
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- End date
- Feb 7, 2024
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- participants needed
- 20
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- sponsor
- University Health Network, Toronto
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.
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.
Details
| Condition | Adenocarcinoma, Malignant Adenoma, Adenocarcinoma, Liver transplant, Liver Transplantation, HEPATIC NEOPLASM, Liver Cancer, HEPATOCELLULAR CARCINOMA, Recurrent Carcinoma, Recurrent Cancer, Liver Cancer, Malignant Adenoma, Liver Transplantation, liver cell carcinoma |
|---|---|
| Treatment | Cabozantinib |
| Clinical Study Identifier | NCT04204850 |
| Sponsor | University Health Network, Toronto |
| Last Modified on | 18 April 2021 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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