Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540937
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-02-18
Brief Title:
Phase II Clinical Study of Leflunomide in the Treatment of MEN-1 Neuroendocrine Tumor
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Clinical Study of Leflunomide in the Treatment of MEN-1 Neuroendocrine Tumor
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies aim to evaluate the initial efficacy of leflunomide tablets in second-line treatment of advanced MEN-1 neuroendocrine tumors and to provide evidence for phase III clinical trials
Detailed Description:
1 Treatment methods Eligible patients will receive leflunomide tablets 20 mg orally once a day before bed every 28 days until the disease progresses or adverse reactions become intolerable
2 Follow-up Eligible patients should follow the requirements of the study protocol and continue to the end of the study The purpose of the follow-up is to know whether the subjects have adverse reactions to the treatment effect and take appropriate treatment Evaluation should be conducted every two cycles If the test is terminated before disease progression the subjects should be followed up every 6 weeks for imaging examination to observe whether the tumor progresses Other antitumor therapy hepatotoxic drugs phenylbutazone phenytoin methotrexate methyldopa rifampicin and traditional Chinese medicine were not allowed before the group withdrawal
At each follow-up the patients history is taken and the following examinations are performed physical examination Blood routine urine routine liver and kidney function serum tumor markers electrocardiogram Tumor imaging eg chest and abdominal CT Blood biomarker test other tests required for the condition
3 Tumor tissueblood biomarker examination In this project the mutation of MEN-1 gene of the patient should be tested and blood samples of the patient and tumor tissue samples remaining during routine diagnosis and treatment should be collected The remaining samples will be returned to the Cancer Hospital of Chinese Academy of Medical Sciences for storage The results of these tests will determine whether the patient can participate in the study
2 Follow-up Eligible patients should follow the requirements of the study protocol and continue to the end of the study The purpose of the follow-up is to know whether the subjects have adverse reactions to the treatment effect and take appropriate treatment Evaluation should be conducted every two cycles If the test is terminated before disease progression the subjects should be followed up every 6 weeks for imaging examination to observe whether the tumor progresses Other antitumor therapy hepatotoxic drugs phenylbutazone phenytoin methotrexate methyldopa rifampicin and traditional Chinese medicine were not allowed before the group withdrawal
At each follow-up the patients history is taken and the following examinations are performed physical examination Blood routine urine routine liver and kidney function serum tumor markers electrocardiogram Tumor imaging eg chest and abdominal CT Blood biomarker test other tests required for the condition
3 Tumor tissueblood biomarker examination In this project the mutation of MEN-1 gene of the patient should be tested and blood samples of the patient and tumor tissue samples remaining during routine diagnosis and treatment should be collected The remaining samples will be returned to the Cancer Hospital of Chinese Academy of Medical Sciences for storage The results of these tests will determine whether the patient can participate in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None