Clinical trial · Interventional
Phase II Clinical Study of Leflunomide in the Treatment of MEN-1 Neuroendocrine Tumor
NCT06540937CI-TRIAL-00079531unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leflunomide Pill | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Leflunomide tablets (20 mg orally, once a day, before going to bed) were administered every 28 days
- description
- 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.
- interventionNames
- Drug: Leflunomide Pill
Primary outcomes (2)
- measure
- Overall response rate (ORR) assessed by RECIST 1.1
- timeFrame
- up to 36 weeks
- description
- ORR is defined as the percentage of patients with a complete response (CR) or partial response (PR) according to RECIST v1.1.
- measure
- Progression-free survival (PFS)
- timeFrame
- up to 36 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMa Y, Zhu Q, Wang X, Liu M, Chen Q, Jiang L, Chi Y, Zeng YX, Zhao H, Jiao Y. Synthetic lethal screening identifies DHODH as a target for MEN1-mutated tumor cells. Cell Res. 2022 Jun;32(6):596-599. doi: 10.1038/s41422-022-00613-1. Epub 2022 Feb 15. No abstract available. PMID 35169281