The clinical trial titled "A Randomized, Controlled, Open-Label, Multi-center, Phase II/III Clinical Study to Evaluate the Safety and Efficacy of CHA for Injection in the Treatment of Recurrent Grade IV Glioblastoma (GBM)" was officially launched at Chongqing University Cancer Hospital on April 25, 2019, and at Cancer Hospital of Harbin Medical University on May 7, 2019. It publicly recruited recurrent glioblastoma patients who met the inclusion criteria from the society.

Clinical Trial Information

1.Major inclusion criteria

(1) Aged 18 years or above, regardless of gender;
(2) Histologically confirmed as GBM; patients who have failed to respond to standard treatments including surgery, radiotherapy and temozolomide, and have been diagnosed as having recurrent GBM this time;
(3) Having undergone enhanced cranial MRI and magnetic resonance spectroscopy within 2 weeks, and having at least one measurable tumor lesion.
(4) Karnofsky Performance Status (KPS) score of ≥ 60 points;
(5) Expected survival period of ≥ 3 months;
(6) Female subjects must not be breastfeeding, and must have a negative result in the blood pregnancy test conducted within 7 days before the first administration.
(7) Voluntarily participating in this study and signing the informed consent form, and being able to understand and comply with all the requirements of the study.

2、Trial grouping design

Trial classification: Randomized, controlled, open-label
Number of participants: 200 cases
Eligible subjects who pass the screening can enter this study. According to the dosing regimen, they will be randomly assigned to the experimental group or the control group to receive the corresponding drug treatment. The experimental group uses CHA for injection, administered by intramuscular injection for 28 consecutive days, followed by a 7-day drug-free period. One dosing cycle is 5 weeks. The control group uses lomustine, administered orally at a dose of 110 mg/m², once every 6 weeks, with a maximum of 4 treatment cycles.

3、Risk and Benefit

By participating in this research project, subjects may potentially experience an extension of their overall survival time and an improvement in their quality of life. Moreover, through the research of this project, they can have a clearer understanding of their own disease conditions, which is beneficial for personalized treatment and various nursing support. However, there is no guarantee that they will definitely benefit from the treatment, and patients may also deteriorate due to ineffective treatment or some other potential diseases. The latest information obtained from this research on the treatment of glioma with CHA for injection will be beneficial to the treatment of patients with similar diseases.

4、Relevant Explanations

The examination fees and outpatient/inpatient fees involved for the subjects participating in this clinical study are free of charge. The project team will provide the treatment medications (including CHA for injection and lomustine) free of charge. During the follow-up process, a certain amount of transportation subsidy will be provided. The project team will provide clinical trial insurance for the subjects, which is used to cover the treatment costs and corresponding economic compensation for the subjects who suffer from damages or death related to the trial.

Contact Information

Telephone Consultation:
If you are interested in participating in this research and would like to learn more details about this research or the research drug, you can consult the following doctors:

Chongqing University Cancer Hospital
Contact Doctor: Cai Run
Contact Telephone Numbers: 023-65075643 / 023-65075646
Contact Address: Department of Neurosurgery Oncology, 14th Floor, Surgical Building, Chongqing University Cancer Hospital, No. 181 Hanyu Road, Shapingba District, Chongqing

Cancer Hospital of Harbin Medical University
Contact Doctor: Doctor Su
Contact Telephone Number: 0451-85718189
Contact Address: The First Ward of Neurosurgery, Cancer Hospital Affiliated to Harbin Medical University, No. 150 Haping Road, Harbin