Clinical Trials Logo
  1. Home
  2. GBM
  3. NCT03758014

Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Grade IV GBM Patients

GBM Clinical Trial

Official title:
A Randomized, Control, Open-label, Multicenter, Phase II/III Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Grade IV GBM Patients

Clinical Trial 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 months）after the first dose of chlorogenic acid for injection and Lomustine.

Clinical Trial 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 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 . ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03758014
Study type Interventional
Source Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
Contact Wenbin Li
Phone 8615301377998
Email neure55@126.com
Status Recruiting
Phase Phase 2/Phase 3
Start date November 27, 2018
Completion date April 30, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06147505 - Natural Killer (NK) Cells (XS005) Injection Combined With Stupp Regimen for Adjuvant Chemotherapy in Subjects With Primary Glioblastoma(GBM) Phase 1/Phase 2
Recruiting NCT05076513 - Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma Early Phase 1
Recruiting NCT04528680 - Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma Phase 1/Phase 2
Terminated NCT03149575 - VAL-083 Phase 3 Study in Temozolomide-Avastin (Bevacizumab) Recurrent GBM Phase 3
Completed NCT01478178 - Safety Study of VAL-083 in Patients With Recurrent Malignant Glioma Phase 1/Phase 2
Terminated NCT03119064 - BrUOG 329 Onivyde & Metronomic Temozolomide in Recurrent Glioblastoma Phase 1/Phase 2
Recruiting NCT05686798 - Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma. Phase 1
Terminated NCT01205334 - Administration of CMV-Specific Cytotoxic T Cells in Patients With Glioblastoma Multiforme Phase 1/Phase 2
Active, not recruiting NCT00114309 - 131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma Phase 2
Not yet recruiting NCT03746288 - To Evaluate the Efficacy and Safety of CAN008 Combined With Re-irradiation (rRT) for Treating Patients With Recurrent Glioblastoma (GBM) Phase 2
Terminated NCT04681677 - Recurrent GBM Treated With Neurosurgical Resection and IORT Using the Xoft Axxent eBx System and Bevacizumab Phase 2
Completed NCT01856933 - BrUOG 263: Prostate Specific Membrane Antigen (PSMA) Glioblastoma Multiforme (GBM) Phase 2
Terminated NCT04763031 - Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT N/A
Completed NCT00107003 - GW572016 to Treat Recurrent Malignant Brain Tumors Phase 2
Completed NCT03426891 - Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma Phase 1
Recruiting NCT06092255 - A Study of SVZ Irradiation With Postoperative Radiotherapy in Patients With GBM. N/A
Recruiting NCT04115761 - Evaluate the Efficacy and Safety of ADCV01 as an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients Phase 2
Recruiting NCT05954858 - Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma N/A
Not yet recruiting NCT06388733 - A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma Phase 3
Recruiting NCT02861898 - Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma Phase 1/Phase 2