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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.
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorogenic Acid for Injection | Experimental | 3 mg/kg per day, injection for 28 days,5 weeks per circle; max. 8 circles |
|
| Lomustine | Active Comparator | 110 mg/m2 taken as a single oral dose every 6 weeks; max. 4 circles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorogenic acid for Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | Through study completion(an average of 18 months)after the first dose of chlorogenic acid for injection and Lomustine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenbin Li | Contact | 8615301377998 | neure55@126.com | |
| Zhuang Kang | Contact | 8615011281069 | kzhaoren1984@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenbin Li | Beijing Tian Tan Hospital,Capital Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D002726 | Chlorogenic Acid |
| D007267 | Injections |
| D008130 | Lomustine |
| ID | Term |
|---|---|
| D002934 | Cinnamates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Lomustine | Drug | Lomustine (INN), abbreviated as CCNU (original brand name (formerly available) is CeeNU, now marketed as Gleostine), is an alkylating nitrosourea compound used in chemotherapy. It is closely related to semustine and is in the same family as streptozotocin. It is a highly lipid-soluble drug, thus it crosses the blood-brain barrier. This property makes it ideal for treating brain tumors, which is its primary use. |
|
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| 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 |
| D003509 |
| Cyclohexanecarboxylic Acids |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |