Pilot Study of Anlotinib in Combination With STUPP Regimen for Treatment of Patients With Newly Diagnosed Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The purpose of this study is to test the the efficacy and safety of Anlotinib in combination with STUPP regimen for patients with newly diagnosed glioblastoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary, pathologically confirmed glioblastoma, and complete molecular biological marker tests (MGMT, 1p/19q, IDH, TERT, BRAF, p53, EGFR);
- •2 ~ 6 weeks after operation; the surgical incision healed well;
- •Presence of lesions evaluable according to Rano criteria;
- •Aged 18-70 years;
- •Karnofsky performance status (KPS) ≥ 60;
- •The dose of corticosteroid therapy was stable or gradually reduced in the past 5 days;
- •No previous radiotherapy, chemotherapy, immunotherapy, or biologic therapy;
- •Serum hemoglobin ≥ 100 g/L, platelet count ≥ 80 × 109/L, neutrophil count ≥ 1.5 × 109/L;
- •Serum creatinine ≤ 1.25 × ULN or creatinine clearance ≥ 60 mL/min;
- •Serum bilirubin ≤ 1.5 × ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN, alkaline phosphatase ≤ 5 × ULN;
- •Normal coagulation function (PT prolongation does not exceed 3s, APTT prolongation does not exceed 10s);
- •Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use an appropriate method of contraception during the trial and 8 days after administration of the trial drug. Males must agree to use an appropriate method of contraception or be surgically sterile during the trial and after 8 weeks of trial drug administration;
- •Patient is sufficiently compliant with study and follow-up procedures;
- •Patients signed a formal informed consent form to indicate that they understood that the study was in accordance with hospital policy and ethical requirements.
排除标准
- •Secondary glioblastoma;
- •Patients with any other malignant tumor before or now, except skin non-melanotic carcinoma or cervical carcinoma in situ;
- •Any other diseases or conditions are contraindications to chemoradiotherapy (such as active phase of infection, within 6 months after cerebral myocardial infarction, symptomatic heart disease including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
- •Pregnant or lactating women;
- •Women and men who are likely to become pregnant but are unwilling to take appropriate contraceptive measures;
- •Evidence of hereditary bleeding constitution or coagulation disorders;
- •Patients requiring anticoagulant therapy due to other diseases;
研究组 & 干预措施
single-arm
single-arm Drug: Anlotinib Drug: Temozolomide Radiotherapy:Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy.
干预措施: Drug is Anlotinib. (Drug)
single-arm
single-arm Drug: Anlotinib Drug: Temozolomide Radiotherapy:Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy.
干预措施: Drug is Temozolomide Capsule. (Drug)
single-arm
single-arm Drug: Anlotinib Drug: Temozolomide Radiotherapy:Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy.
干预措施: Radiotherapy was initiated 4 to 6 weeks postoperatively. (Radiation)
结局指标
主要结局
PFS
时间窗: from enrollment to progression or death (for any reason),assessed up to 18months
Progression-Free Survival
次要结局
- OS(from enrollment to death (for any reason).assessed up to 24 months)
- adverse event(from enrollment to death (for any reason).assessed up to 24 months)
- Health-related quality of life(from enrollment to death (for any reason).assessed up to 24 months)
- Neurocognitive function(from enrollment to death (for any reason).assessed up to 24 months)
研究者
Chen yuanyuan
MD
Zhejiang Cancer Hospital