Status:
UNKNOWN
Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Grade IV GBM Patients
Lead Sponsor:
Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
Conditions:
GBM
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 mo...
Detailed Description
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 activit...
Eligibility Criteria
Inclusion
- Age ≥ 18;
- KPS ≥ 60;
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
November 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03758014
Start Date
November 27 2018
End Date
April 30 2021
Last Update
November 29 2018
Active Locations (1)
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1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China