STUPP Regimen With or Without Lenvatinib for Newly Diagnosed Glioblastoma With MGMT Promoter Methylation: A Multicenter, Randomized Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 138
- 主要终点
- Progression-Free Survival（PFS）
研究概览
简要总结
To compare the efficacy and safety of Lenvatinib combined with the standard Stupp regimen versus the standard Stupp regimen alone in the treatment of newly diagnosed glioblastoma with MGMT promoter methylation positive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed GBM confirmed by post-op pathology/biopsy, MGMT promoter methylation positive, no prior RT or chemo.
- •Surgery/biopsy ≤ 21 days before enrollment.
- •Age 18-75 years any gender.
- •Organ function (no blood components or growth factors within 14 days):
- •ANC ≥ 1.5 × 10⁹/L; PLT ≥ 100 × 10⁹/L; Hb ≥ 90 g/L.
- •Total bilirubin ≤ 1.5 × ULN.
- •ALT, AST ≤ 3 × ULN.
- •Serum creatinine ≤ 1.5 × ULN or CrCl ≥ 50 mL/min.
- •Life expectancy ≥ 12 weeks.
- •Stable or tapering corticosteroid dose for 14 days.
- •Voluntary participation, signed informed consent, and good compliance.
排除标准
- •Allergy to Lenvatinib, TMZ, or components.
- •Other malignancies within 5 years or concurrent, or prior anti-tumor therapy.
- •Concurrent participation in another clinical trial (except observational).
- •Comorbidities interfering with treatment:
- •Grade 4 non-hematological toxicity (except hair loss, nausea, vomiting).
- •Conditions interfering with oral drugs (dysphagia, chronic diarrhea, bowel obstruction).
- •Evidence of increased intracranial pressure (midline shift > 5 mm, papilledema, vomiting, decreased consciousness).
- •History of drug/alcohol abuse.
- •Pregnancy or lactation.
- •Other conditions judged by the investigator (e.g., unstable heart/kidney disease, uncontrolled diabetes, mood disorders).
研究组 & 干预措施
experimental group：Lenvatinib + TMZ + radiotherapy
Lenvatinib + TMZ + radiotherapy：During RT, TMZ 75 mg/m² po QD and Lenvatinib 20 mg po QD; 4 weeks after RT, 6 cycles of TMZ maintenance; Lenvatinib continues at 20 mg QD post-RT until progression or intolerable toxicity.
干预措施: radiotherapy (Radiation)
control group：TMZ + radiotherapy
TMZ + radiotherapy：During RT, TMZ 75 mg/m² po QD; 4 weeks after RT, 6 cycles of TMZ (150-200 mg/m² po D1-D5, Q4W) maintenance.
干预措施: radiotherapy (Radiation)
experimental group：Lenvatinib + TMZ + radiotherapy
Lenvatinib + TMZ + radiotherapy：During RT, TMZ 75 mg/m² po QD and Lenvatinib 20 mg po QD; 4 weeks after RT, 6 cycles of TMZ maintenance; Lenvatinib continues at 20 mg QD post-RT until progression or intolerable toxicity.
干预措施: TMZ (Temozolomide) (Drug)
experimental group：Lenvatinib + TMZ + radiotherapy
Lenvatinib + TMZ + radiotherapy：During RT, TMZ 75 mg/m² po QD and Lenvatinib 20 mg po QD; 4 weeks after RT, 6 cycles of TMZ maintenance; Lenvatinib continues at 20 mg QD post-RT until progression or intolerable toxicity.
干预措施: Lenvatinib (Drug)
control group：TMZ + radiotherapy
TMZ + radiotherapy：During RT, TMZ 75 mg/m² po QD; 4 weeks after RT, 6 cycles of TMZ (150-200 mg/m² po D1-D5, Q4W) maintenance.
干预措施: TMZ (Temozolomide) (Drug)
结局指标
主要结局
Progression-Free Survival（PFS）
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
defined as the time from enrollment to the first documented local-regional recurrence, distant metastasis, or death from any cause
次要结局
- Overall survival (OS)(From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 36 months)
- Best Overall Response (BOR)(36 months)
- Safety evaluation(During the concurrent chemoradiotherapy phase; Weekly during maintenance chemotherapy cycles 1-6 (the worst result within each cycle will be recorded); At the end of treatment or disease progression. whichever came first, assessed up to 36 months.)
- Function quality of Life(Before the concurrent chemoradiotherapy phase; Weekly before maintenance chemotherapy cycles 1-6 (the worst result within each cycle will be recorded); At the end of treatment or disease progression. whichever came first, assessed up to 36 months.)
- Brain tumor symptom burden(Before the concurrent chemoradiotherapy phase; Weekly before maintenance chemotherapy cycles 1-6 (the worst result within each cycle will be recorded); At the end of treatment or disease progression. whichever came first, assessed up to 36 months.)