NCT06540937

Phase II Clinical Study of Leflunomide in the Treatment of MEN-1 Neuroendocrine Tumor

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 patient's 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 (e.g., chest and abdominal CT); Blood biomarker test; other tests required for the condition. 3. Tumor tissue/blood 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.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Leflunomide Pill	This is a single-arm, single-center, phase II clinical study. Primarily evaluated in advanced MEN-1 neuroendocrine tumors. The initial efficacy of leflunomide tablets in second-line treatment provided evidence for phase III clinical trials.

Timeline

• Start date: 2020-07-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2024-08-07
• Last updated: 2024-08-07

Locations

1 site across 1 country: China