Glioma
Conditions
Interventions
Experimental group:Temozolomide (TMZ): 200 mg/m^2 orally once daily (PO qd) on days 1–5 of a 28-day cycle
Leflunomide: Loading dose of 50 mg/day on days 1–3, followed by maintenance dose of 20 mg/day
each 28 days constitutes one cycle.
Sponsors
The First Affiliated Hospital of Xinxiang Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand this study and voluntarily sign the informed consent form; 2. Age >=18 years and =10mm); 4. PS score 0-1; 5. Expected survival >=12 weeks; 6. Study participants agree to use reliable contraceptive methods from signing the informed consent throughout the clinical study; 7. No history of other malignant tumors, except for cured skin basal cell or squamous cell carcinoma, or carcinoma in situ of the cervix; 8. Liver function: TBIL = 4.0×10^9/L, Hb >= 90 g/L, PLT >= 80×10^9/L.
Exclusion criteria
Exclusion criteria: 1. Brain glioma combined with other pathological types of tumors; 2. Any surgical or invasive treatment or procedure within 4 weeks before enrollment (excluding intravenous catheterization, puncture drainage, biopsy, etc.); 3. Patients with evidence or history of significant bleeding tendencies within 3 months before enrollment (bleeding >30 mL within 3 months, vomiting blood, melena, hematochezia), hemoptysis (fresh blood >5 mL within 4 weeks), or thromboembolic events within 12 months (including stroke events and/or transient ischemic attacks); 4. Pregnant or breastfeeding women (women of childbearing age must undergo pregnancy testing); 5. Patients with chronic active hepatitis, AIDS, or syphilis; 6. Severe allergic constitution; 7. Severe psychiatric disorders; 8. Patients with severe heart, liver, or kidney dysfunction, uncontrolled diabetes, or other serious diseases; 9. Unresolved toxic reactions of grade higher than CTCAE v5.01 caused by any previous anti-cancer treatment, excluding hair loss and grade <=2 neurotoxicity caused by TMZ; 10. Other situations deemed unsuitable for participation in this study by the investigator, or other situations affecting the analysis of this clinical study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor volume;OverallSurvival, OS;Progression-Free Survival, PFS;ObjectiveResponse Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DiseaseControlRate, DCR;DurationofResponse, DoR;QualityofLife, QoL; | — |
Countries
China
Contacts
Public ContactFazheng Shen
The First Affiliated Hospital of Xinxiang Medical University
Outcome results
None listed