Chidamide for Advanced Cephalic and Cervical Adenocystic Carcinoma: Evaluation of Efficiency and Safety

Study Overview
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Brief Summary
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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.

Official Title
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Chidamide for Advanced Cephalic and Cervical Adenocystic Carcinoma: Evaluation of Efficiency and Safety

Conditions
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Adenocystic Carcinoma

Intervention / Treatment
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* Drug: Chidamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of advanced cephalic and cervical adenocystic carcinoma with pathological and imaging evidences, with local relapse or metastasis or refractory towards treatment. Age 18-75, male or female, expected survival≥ 3 months. ECOG 0-2. With at least one evaluable disease focus. Organ functions should fit the following: 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: History of HDACI treatment. Women during pregnancy or lactation. Patients with a second primary tumor ( this does not include non-melanoma skin cancer received systemic treatment, cured cervical carcinoma in situ of the uterus, or other tumors that have been cured with disease free survival˃ 5 years) Patients with central nervous system defects or mental disorders. Other diseases or contraindications: History of heart disease within 6 months prior to inclusion, including NYHA III-IV heart failure after treatment, coronary heart disease, angina pectoris, myocardial infarction, degree II or III atrioventricular block, severe arrhythmias that need medical treatment, uncontrolled hypertension; liver cirrhosis (Child-Pugh B or C); active infection that has not been controlled, and other conditions that may make the patient unable to complete the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chidamide<br>Patients of advanced cephalic and cervical adenocystic carcinoma are given Chidamide 30mg,biw, then the efficacy and safety will be accessed. | Drug: Chidamide<br> <br> * Other names: epidaza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cephalic and cervical adenocystic Carcinoma, Chidamide