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The purpose of this trial is to evaluate the efficiency and safety of Chidamide in advanced cephalic and cervical adenoid cystic carcinoma. Chidamide is given to patients with advanced cephalic and cervical adenoid cystic carcinoma with the dosage of 30mg,twice a week, then overall survival, event-free survival are accessed for efficiency, and laboratory tests about the function of vital organs are accessed for safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chidamide | Experimental | Patients of advanced cephalic and cervical adenocystic carcinoma are given Chidamide 30mg,biw, then the efficacy and safety will be accessed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate | percentage of patients who get complete remission, partial remission and stable disease. | through study completion, an average of 33 months |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicities | Hematologic toxicities and non-hematologic toxicities including nausea，vomiting，liver, heart and other organ disfunctions. | every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months |
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Inclusion Criteria:
Liver: Total bilirubin ≤ 1.5 times of the normal maximum, ALT and AST≤ 2.5 times of the normal maximum. (ALT/AST≤ 5 times of the normal maximum for patients with infiltrative liver disease) Kidney: Serum creatinine ˂ 1.5 folds of the normal maximum; creatinine clearance rate ≥50ml/min (calculated by Cockroft-Gault10 formula)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei Dong, Doctor | Contact | （+86）10-87788130 | Dongmei030224@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Mei Dong, Doctor | Cancer Hospital Chinese Academy of Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Science | Recruiting | Beijing | Beijing Municipality | 100021 | China |
The data of the trial would be accessable on the corresponding website after the trial has been finished.
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| ID | Term |
|---|---|
| D003528 | Carcinoma, Adenoid Cystic |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
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| QOL score |
improvement of patients' feeling and quality of daily life |
| every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months |
| D009369 | Neoplasms |