OncoMatch/Clinical Trials/NCT06540937
Phase II Clinical Study of Leflunomide in the Treatment of MEN-1 Neuroendocrine Tumor
Is NCT06540937 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Leflunomide Pill for neuroendocrine tumors.
Treatment: Leflunomide Pill — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Biomarker criteria
Required: MEN1 germ line mutation
MEN-1 germ line mutation (MEN-1 syndrome)
Required: MEN1 somatic mutation
tumor with somatic MEN-1 mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — first-line
Unresectable neuroendocrine tumors that have failed standard first-line systemic therapy
Cannot have received: antitumor therapy
Received any antitumor therapy within 4 weeks
Lab requirements
Blood counts
leukocyte > 4.0×10^9/L, neutrophils ≥ 1.5×10^9/L, platelets ≥ 100×10^9/L, hemoglobin ≥ 10 g/dL
Kidney function
serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 60 ml/min
Liver function
total bilirubin < 1.5x ULN, AST/ALT ≤ 1.5x ULN, LDH ≤ 1.5x ULN, alkaline phosphatase ≤ 5x ULN
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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