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| Name | Class |
|---|---|
| Beijing Shijitan Hospital, Capital Medical University | 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 Glioblastoma Patients ;
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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 30 days after the first dose of chlorogenic acid | |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0,grade ≥3 (DLT) | 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 | |
| Area under the plasma concentration versus time curve (AUC) of chlorogenic acid | Within the first 30 days after the first dose of chlorogenic acid | |
| Peak Plasma Concentration (Cmax) of chlorogenic acid | Within the first 30 days after the first dose of chlorogenic acid |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in cancer-related symptoms | Within 1 year after the first dose of chlorogenic acid | |
| disease control rate(DCR) | Within the first 30 days after the first dose of chlorogenic acid | |
| Measure | Description | Time Frame |
|---|---|---|
| Changing in number of red blood cell | Within 1 year after the first dose of chlorogenic acid | |
| Changing in cytokines in peripheral blood | Within 1 year after the first dose of chlorogenic acid | |
Inclusion Criteria:
1)PLT count≥100×10~9/L, 2)WLB count≥4.0×10~9/L and ≤12×10~9/L, 3)Neutrophil granulocyte count≥2.0×10~9/L, 4)HGB count≥90g/L, 5)Total bilirubin <=1.5 times of ULN, 6)ALT/AST ≤2.5 times of ULN, 7)SCr≤1.5 times of ULN, 8)Normal ECG with LVEF (≥50%) measured by echocardiography; 6.Female patients with negative pregnant test, and male/female patients of reproductive age without pregnancy planning in the next 12 months; 7.Volunteered for the phase 1 trial and sign the informed consent without protest;
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Shijitan Hospital,Capital Medical University | Beijing | 100038 | 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 |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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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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|
| objective response rate (ORR) |
| Within the first 30 days after the first dose of chlorogenic acid |
| progress free survival(PFS) | Within the first 30 days after the first dose of chlorogenic acid |
| overall survival (OS) | Within the first 30 days after the first dose of chlorogenic acid |
| Improvement in quality of life | Within 1 year after the first dose of chlorogenic acid |
| Changing in level of hemoglobin |
| Within 1 year after the first dose of chlorogenic acid |
| Changing in lymphocyte subsets | Within 1 year after the first dose of chlorogenic acid |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D003509 |
| Cyclohexanecarboxylic Acids |