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

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.

Eligibility

Inclusion Criteria:

* 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 Criteria:

* 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

Conditions2

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