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Chlorogenic acid for injection(30mg/bottle) is white or off-white freeze-dried lump or powder,it can be easily dissolved in water, which solubility is 20%.

Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.

Chlorogenic acid

Sheng Yang, Dr

Jianping Xu, Dr

Yuankai Shi, Dr

This Ib / IIa clinical trial program focuses on the small cell lung cancer (SCLC), Squamous non-small cell lung cancer (NSCLC) and adeniform NSCLC in order to start a better development on the broad-spectrum value of chlorogenic acid： Determine the Disease control rate（DCR）of phase Ib/IIa of Chlorogenic acid for injection in the advanced Lung Cancer Patients.

1. Determine the Disease control rate（DCR）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
2. Determine the Overall Survival（OS）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
3. Determine the Objective response rate（ORR）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
4. Determine the Progression Free Survival（PFS）of Chlorogenic acid for injection in the advanced Lung Cancer Patients;
5. Determine Eastern Cooperative Oncology Group（ECOG）.

Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer

A Single Arm, Open-label, Multicenter, Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer Patients

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd

Lin Shen, Dr

The purpose of this study:

Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the advanced malignant tumor subjects;

1. Investigate the tolerance of Chlorogenic acid for injection in human body, determine the Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT) of Chlorogenic acid for injection in the advanced malignant tumor subjects;
2. Determine the human pharmacokinetics characteristic of Chlorogenic acid for injection;
3. Preliminary observation the effectiveness and effective dose;
4. Provide the basis for the dosage regimen of phase II/III.

Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers

Peking University Cancer Hospital & Institute

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

The purpose of this study:

Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the advanced Glioblastoma Patients ;

1. Investigate the tolerance of Chlorogenic acid for injection in human body, determine the Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT) of Chlorogenic acid for injection in the advanced Glioblastoma Patients ;
2. Determine the human pharmacokinetics characteristic of Chlorogenic acid for injection;
3. Preliminary observation the effectiveness and effective dose;
4. Provide the basis for the dosage regimen of phase II/III.

Tolerance and Pharmacokinetic Study of Chlorogenic Acid to Advanced Glioblastoma

Phase 1 Trial of Tolerance and Pharmacokinetic of Chlorogenic Acid for Injection in the Advanced Glioblastoma Patients

Beijing Shijitan Hospital, Capital Medical University

chlorogenic acid

Yuankai Shi, Dr.

The purpose of the study is to explore if chlorogenic acid is safe in patients with cancer.

Phase 1 Trial of Chlorogenic Acid in Patients With Advanced Cancer

Phase 1 Trial Evaluating Tolerability and Pharmacokinetics of Chlorogenic Acid for Injection in Patients With Advanced Cancer

Chinese Academy of Medical Sciences

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer	NCT03751592	Advanced Lung C...	Chlorogenic aci...	18 Years -	Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers	NCT02245204	Advanced Cancer	Chlorogenic aci...	18 Years - 65 Years	Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers	NCT02245204	Advanced Cancer	Chlorogenic aci...	18 Years - 65 Years	Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
Tolerance and Pharmacokinetic Study of Chlorogenic Acid to Advanced Glioblastoma	NCT02728349	Glioblastoma	Chlorogenic aci...	18 Years - 65 Years	Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
Tolerance and Pharmacokinetic Study of Chlorogenic Acid to Advanced Glioblastoma	NCT02728349	Glioblastoma	Chlorogenic aci...	18 Years - 65 Years	Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd
Phase 1 Trial of Chlorogenic Acid in Patients With Advanced Cancer	NCT02136342	Advanced Cancer	chlorogenic aci...	18 Years - 65 Years	ChineseAMS
Phase 1 Trial of Chlorogenic Acid in Patients With Advanced Cancer	NCT02136342	Advanced Cancer	chlorogenic aci...	18 Years - 65 Years	ChineseAMS
Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer	NCT03751592	Advanced Lung C...	Chlorogenic aci...	18 Years -	Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd

Spots Global Cancer Trial Database for chlorogenic acid