NCT06220552招募中2 期
Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma: A Single-arm, Prospective Phase II Clinical Study
Fifth Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年12月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- progression free survival (PFS)
研究概览
简要总结
This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of low-dose radiotherapy combined with programmed death 1 (PD-1) inhibitor (sintilimab) and temozolomide in recurrent glioblastoma. The eligible patients are scheduled to administered sintilimab 200mg D1 Q3W temozolomide 50mg/m2 QD and radiotherapy 1Gy/1F D1/D2/D8/D15 Q3W for 4-6 cycles, then sintilimab for maintenance. The overall primary study hypothesis is that the combination regimen of low-dose radiotherapy, sintilimab and temozolomide is safe and feasible in the treatment of recurrent 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed glioblastoma, radiographically or pathologically diagnosed recurrence.
- •Aged ≥ 18 years.
- •≥12 weeks after postoperative radiotherapy.
- •Karnofsky performance status (KPS) ≥
- •Expected survival > 3 months.
- •Adequate organ function, based on meeting all of the following criteria (no blood components and cytologic growth factors were received within 14 days prior to the test):
- •Hemoglobin ≥ 90 g/L; absolute neutrophil count ≥ 1.5 × 10^9/L; and platelet count ≥ 100 × 10^9/L;
- •Serum albumin ≥ 28 g/L;
- •Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;
- •Serum creatinine ≤ 1.5 × ULN;
- •Activated partial clotting enzyme time and international standardized ratio (INR) ≤ 1.5 × ULN (Patients on stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the expected treatment range of anticoagulants can be screened ).
- •Thyroid stimulating hormone ≤ ULN; If abnormal, T3 and T4 levels should be examined, and if T3 and T4 levels are normal, they can be screened.
- •Subjects voluntarily join the study and sign an informed consent form, with good compliance.
排除标准
- •Treatment with a dose of prednisone > 10mg /d or equivalent dose of corticosteroids is required.
- •There exist other uncontrolled central nervous system diseases unrelated to cancer.
- •A history of other malignant tumors within the previous 5 years or at the time of enrollment, except for cured skin basal cell carcinoma and cervical in situ cancer, as well as thyroid papilloma.
- •Uncontrolled cardiac clinical symptoms or diseases, such as New York Heart Association (NYHA) class II or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention.
- •Serious infections, such as severe pneumonia, bacteremia, and infection comorbidities requiring hospitalization, occurred within 4 weeks.
- •Active autoimmune diseases, such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; It does not include patients with vitiligo or childhood asthma/allergies that have healed and require no intervention as adults.
- •A history of immunodeficiency, including HIV-positive status or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and bone marrow transplantation.
- •Patients with active tuberculosis infection found by history or CT examination, or patients with active tuberculosis infection history within 1 year prior to enrollment, or patients with active tuberculosis infection history before 1 year without formal treatment.
- •Active hepatitis B (HBV DNA ≥ 2,000 IU/mL or 10,000 copies/mL) or hepatitis C (positive HCV antibody test and HCV RNA above the lower limit of detection).
- •Known history of psychotropic drug abuse, alcoholism and drug use.
- •Not suitable for inclusion, as judged by the investigator.
研究组 & 干预措施
Low-dose Radiotherapy Combined With Sintilimab and Temozolomide
Experimental
干预措施: Sintilimab (Drug)
Low-dose Radiotherapy Combined With Sintilimab and Temozolomide
Experimental
干预措施: Low-dose Radiotherapy (Radiation)
结局指标
主要结局
progression free survival (PFS)
时间窗: from the first day of treatment to the follow up of 1 year
median progression free survival
次要结局
- Adverse events(from the first day of treatment to the follow up of 1 year)
- overall survival (OS)(from the first day of treatment to the follow up of 1 year)
研究者
Yingpeng Peng
Director
Fifth Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
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