Clinical Trial Recruitment | The Phase II Clinical Trial of CHA Led by Beijing Tiantan Hospital Has Been Launched

Resource：Jiuzhang Biotech Time：2019.01.31

After being reviewed and approved by the Ethics Committee of Beijing Tiantan Hospital Affiliated to Capital Medical University (Ethics Review No. YW2018 - 018 - 01/02/03), 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)", presided over by Professor Li Wenbin, Director of the Comprehensive Treatment Ward for Neuro - Oncology in the Department of Neurosurgery of Beijing Tiantan Hospital, has been officially launched. After the Spring Festival in 2019, recruitment of recurrent glioblastoma patients who meet the inclusion criteria will officially start from the general public.

This study has been approved by the China Food and Drug Administration (Approval Document No.: 20153L01855), and the trial will be successively carried out in 12 hospitals across the country with Beijing Tiantan Hospital Affiliated to Capital Medical University taking the lead (see the table below for details).

The trial centers that have been launched:

The trial centers that are about to be launched:

Research Background

Current Status of Glioma Treatment:

Gliomas account for 81% of all primary malignant tumors of the central nervous system. Its main pathological types include glioblastoma, anaplastic astrocytoma, anaplastic oligoastrocytoma, etc. In recent years, the incidence rate has been continuously increasing. In particular, glioblastoma has the highest incidence rate. Most malignant gliomas are located in the cerebral hemisphere. The tumor grows relatively fast, and the space-occupying effect of the tumor is obvious. Its main clinical manifestations are symptoms of increased intracranial pressure, namely headache, nausea, vomiting, visual impairment, etc. Other symptoms include mental changes, epileptic seizures, focal neurological symptoms, etc. The severity of the symptoms is related to the size and location of the tumor, the age of the patient, etc.

Malignant gliomas are characterized by rapid progression and high mortality. Taking glioblastoma as an example, its standard treatment plan is to perform maximum surgical resection while ensuring neurological function. After the operation, local radiotherapy is administered simultaneously with oral chemotherapy of temozolomide (75mg/m²), and then 6 cycles of adjuvant chemotherapy with temozolomide (150 - 200 mg/m²) are given. However, due to its high degree of malignancy, strong invasiveness, infiltrative growth and other characteristics, it is difficult to completely resect the tumor by surgery. It is extremely prone to recurrence, and the prognosis is poor. The median survival time after recurrence is only 7.1 - 9.6 months. Currently, there is no generally recognized optimal treatment plan for malignant gliomas that have recurred after standard treatment.

Since temozolomide was approved by the FDA for the treatment of malignant gliomas in 1999, there has been no breakthrough new drug launched globally in the past 20 years. CHA is a natural substance widely present in plants and was discovered by British scholars in 1897. The R&D team of Sichuan Jiuzhang Biotechnology Co., Ltd. was the first in the world to develop the CHA monomer into a drug, carried out systematic pre-clinical research, obtained independent intellectual property rights, and applied it to the research on the treatment of major diseases (cancer). It is a world's first Class 1 anti-cancer new drug independently developed and with independent intellectual property rights.

Currently, the Phase I clinical study of CHA in the treatment of recurrent gliomas led by Director Li Wenbin has been completed. The conclusions show that: 1. Chlorogenic acid has good drug safety; 2. A trend of the effectiveness of chlorogenic acid in treating recurrent gliomas has been observed.

Among them, all the subjects with Grade IV gliomas are patients with multiple recurrences. The median overall survival (OS) (calculated starting from the random administration of the drug) of the subjects with Grade IV gliomas in the effective dose group reaches 21.4 months, while the median OS of patients with Grade IV gliomas with multiple recurrences in the literature is only 3 - 4.6 months.

Currently, the launch meeting of the Phase II clinical trial of chlorogenic acid has been held (see the Launch Meeting of the Phase II Clinical Trial of CHA in the Treatment of Gliomas Held in Beijing Tiantan Hospital, with 14 Centers Nationwide Participating for details). After the Spring Festival in 2019, patients will be recruited for enrollment and treatment.

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 study and would like to learn more details about this study or the research drug, you can consult the following doctor:

Beijing Tiantan Hospital Affiliated to Capital Medical University
Contact Doctor: Kang Zhuang
Contact Telephone Number: 010-59975034
Contact Address: Comprehensive Treatment Ward for Neuro-oncology, New Campus of Beijing Tiantan Hospital (No. 119 Fanyang Road, Fengtai District, Beijing)

For more information, please click to view the original news.

Prev Next