A Randomized, Control, Open-label, Multicenter, Phase II/III Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Grade IV GBM Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall Survival（OS）
研究概览
简要总结
The purpose of phase II/III study: Determining the Overall Survival（OS）of Chlorogenic acid for injection comparing to in the advanced Glioblastoma Patients through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine.
详细描述
Chlorogenic acid (CHA) is a class 1 innovative small molecular natural drug, developed by Sichuan Jiuzhang Biological Science and Technology Co., Ltd. The mechanism of broad-spectrum antitumor activity is immunoregulation. After received the clinical trial approval issued by CFDA, Jiuzhang Biotech successfully finished the phase I clinical studies of CHA for injection in advanced GBM patients, focus on safety, PK, and preliminary efficacy evaluation.
The results of phase I data showed that CHA had good safety, the main adverse effect was induration, no other serious adverse effects. PK exhibited that CHA had a rapid metabolism character (t1/2 = 1-1.5 h). In addition, there were no accumulative side effects for long-term use. To the investigators' surprise, the preliminary efficacy evaluation was amazing, there were 1 case CR and 1 case PR. The median OS of grade IV GBM patients was 21.4 months in effective dose group, which was much better than that of the historical reported data.The purpose of phase II/III study: Determining the Overall Survival（OS）of Chlorogenic acid for injection comparing to in the advanced Glioblastoma Patients through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine .
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
- Single (Investigator)
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
- •Recurrent GBM;
- •Estimated lifetime ≥ 3 months；
- •Female patients with negative pregnant test, and male/female patients of reproductive age without pregnancy planning in the next 12 months;
- •Volunteered for the phase 2 trial and sign the informed consent without protest.
排除标准
- •Patients who have received the therapy of chemotherapy or radical radiotherapy within 1 month before enrollment;
- •Pregnant or breast-feeding women, or patients(male and female) who have pregnancy plan;
- •Patients who had received a therapy of another investigational drug within 1 month；
- •Known active hepatitis B/hepatitis C, positive HIV/ syphilis antibody;
- •Patients who have received therapy of major surgery within 4 weeks or biopsy surgery within 1 week before enrollment;
- •Patient who need long term treatment of cortical hormone or other immunosuppressive drugs such as visceral organ transplanters；
- •Patients who have sufficient baseline organ function and whose laboratory data can meet the following criteria at the enrollment:1)PLT count<80×10~9/L； 2)NEUT# count<1.5×10~9/L ；3)HGB count<90g/L；4)Total bilirubin >1.5 times of ULN；5)ALT/AST >1.5 times of ULN；
- •History of drug abuse；
- •Patients who was treated with Immunologic drugs（DC/CIK/CTL/PD-（L）1） in 3 months;
- •Patients who are false progressers；
- •Patients who can not be received MRI examination；
- •Patients who had severe trauma or infectious diseases within 4 weeks；
- •Patients who had cerebral stroke or Transient ischemic attack within 6 months；
- •Patients who were performed important operations within 4 weeks；
- •Uncontrollable psychopaths;
- •Patients who had other advanced cancers within 5 years；
- •Patients who had grade III or IV heart failure within 6 months；
- •Other patients judged ineligible for enrollment in the study by the investigator (sub-investigator).
研究组 & 干预措施
Chlorogenic Acid for Injection
3 mg/kg per day, injection for 28 days，5 weeks per circle; max. 8 circles
干预措施: Chlorogenic acid for Injection (Drug)
Lomustine
110 mg/m2 taken as a single oral dose every 6 weeks; max. 4 circles
干预措施: Lomustine (Drug)
结局指标
主要结局
Overall Survival（OS）
时间窗: Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine
次要结局
- progress free survival(PFS)(Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine)
- disease control rate（DCR)(Within the first 10 weeks after the first dose of chlorogenic acid for injection and Lomustine)
- objective response rate (ORR)(Within the first 10 weeks after the first dose of chlorogenic acid for injection and Lomustine)
- Karnofsky score standard(Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine)
- Montreal Cognitive Assessment score standard(Through study completion（an average of 18 months）after the first dose of chlorogenic acid for injection and Lomustine)