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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
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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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorgenic acid, Treatment, powder | Experimental | 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%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorogenic acid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Within the first 60 days after the first dose of chlorogenic acid |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting Toxicity | Within the first 30 days after the first dose of chlorogenic acid | |
| Maximum Tolerated Dose | Within the first 30 days after the first dose of chlorogenic acid | |
| Measure | Description | Time Frame |
|---|---|---|
| Changing in number of red blood cell and level of hemoglobin | within 1 year after the first dose of chlorogenic acid | |
| Changing in the diameters of lymph node metastasis | Within 1 year after the first dose of chlorogenic acid |
Inclusion Criteria:
Patients with pathologic or/and FNAC confirmation of advanced cancer but without effective treatment or with treatment failure;
Between 18 and 65 years of age, KPS≥70;
According to RECIST 1.1,patients with at least one tumor lesion that can accurately be measured by CT or MRI in at least one dimension with longest diameter to be recorded as >2.0cm by general CT or >1.0cm by spiral CT;
Life expectancy of at least three (3) months at the enrollment;
Patients who have sufficient baseline organ function and whose laboratory data can meet the following criteria at the enrollment:
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 1 trial and sign the informed consent without protest;
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lin Shen, Dr | Peking University Cancer Hospital & Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40614321 | Derived | Zhu H, Chen J, Dong X, Qin X, Li Z. Influence of dihydrocaffeic acid and quinic acid on lung metabolism and function: Implications for dietary interventions. Biochem Biophys Res Commun. 2025 Sep 1;777:152274. doi: 10.1016/j.bbrc.2025.152274. Epub 2025 Jun 28. |
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| ID | Term |
|---|---|
| D002726 | Chlorogenic Acid |
| ID | Term |
|---|---|
| D002934 | Cinnamates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of chlorogenic acid |
| Within the first 30 days after the first dose of chlorogenic acid |
| Improvement in cancer-related symptoms and quality of life | Within 1 year after the first dose of chlorogenic acid |
| Changing in levels of tumor markers | Within 1 year after the first dose of chlorogenic acid |
| D003509 |
| Cyclohexanecarboxylic Acids |