Status:
RECRUITING
Phase II Clinical Study of Leflunomide in the Treatment of MEN-1 Neuroendocrine Tumor
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
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. Fo...
Eligibility Criteria
Inclusion
- Age 18-75 years, gender unlimited
- Pathological diagnosis of neuroendocrine tumor
- MEN-1 germ line mutation (MEN-1 syndrome), or tumor with somatic MEN-1 mutation
- Unresectable neuroendocrine tumors that have failed standard first-line systemic therapy
- At least one evaluable lesion according to the RECIST criteria
- ECOG physical condition score: 0-1
- Voluntarily joined the study, signed the informed consent, complied well, and cooperated with the follow-up.
- Must meet the following requirements: Bone marrow: leukocyte \> 4.0×109/L, neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥10g/dL; Liver: total bilirubin \< 1.5 times the upper limit of normal, AST/ALT≤1.5 times the upper limit of normal value, Lactate dehydrogenase ≤1.5 times the upper limit of normal value, Alkaline phosphatase ≤5 times the upper limit of normal value; Kidney: serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance ≥60ml/min
Exclusion
- Received any antitumor therapy within 4 weeks
- Participated in or are participating in clinical trials of other drugs/therapies within 4 weeks prior to the initial use of the study drug
- Underwent/received major surgery or has not recovered from the side effects of the surgery within 4 weeks prior to the initial use of the study drug
- Subjects of other malignant tumors unless complete remission was achieved at least 2 years prior to study inclusion and not required other treatment during the study period
- Persistent or active (serious) infection
- Hypertension that is difficult to control with medication (continuous blood pressure is greater than 150/90 MMHG
- Poorly controlled diabetes
- Grade II/IV congestive heart failure or heart block
- Within 6 months prior to use for the first time seen in the following situations:
- Deep vein thrombosis; Pulmonary embolism; Myocardial infarction; Serious arrhythmia; Instability or angina pectoris; Percutaneous coronary intervention; Acute coronary syndrome; Coronary artery bypass grafting
- Be allergic to leflunomide tablets and their metabolites
- Severe liver damage
- Other severe acute or chronic medical conditions or abnormalities in laboratory tests that may increase the risks associated with study participation or may interfere with the interpretation of study results
- Poor compliance, or other conditions unsuitable for participation in this trial
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06540937
Start Date
July 1 2020
End Date
December 30 2024
Last Update
August 7 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China, 100021