Chidamide Combined With Cisplatin in Head and Neck Adenoid Cystic Carcinoma (HNACC)

• Status: Completed
• Trial end date: 2021-06-02
• Target enrollment: 0
• Participant gender: All

Summary

The investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

1. Age range 18-75 years old

2. Histological confirmed recurrent or metastatic head and neck adenoid cystic carcinoma

3. Unable to treat with surgery/radiotherapy, or previously failure to non-cisplatin systematic treatment;

4. Eastern Cooperative Oncology Group performance status 0 to 2;

5. Patients have written informed consent to participate in the study;

6. anticipated to live ≧3 months;

7. Absolute neutrophil count ≥ 1.5×109/L，platelet ≥ 100×109/L，hemoglobin ≥ 90 g/L

8. total bilirubin < 1.5×upper limit of normal(ULN), ALT and AST < 3× ULN

9. serum creatine <1.5×ULN, and creatinine clearance rate (CCR) ≥ 50 ml/min

10. Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed no signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.

11. Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥0.5 cm in short-diameter by CT.

Exclusion Criteria:

1. Previously treated with HDACi;

2. Treated with cisplatin-contained regimes in the past half of the year, and not achieving PR/CR;

3. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;

4. HIV, HCV, or syphilis infection；

5. Pregnant or lactating women;

6. Serious uncontrolled infection;

7. Severe neurol of mental illness, including dementia and epilepsy;

8. Having contraindications to the use of oral medication, such as unable to swallow, nausea and vomiting, chronic diarrhea or suffering from a bowel obstruction;

9. Participated in other clinical trials in 4 weeks;

10. Other coexisting diseases or situations that may cause patients to fail to complete clinical trials;

11. History of QTc interval prolongation (Male >450ms，Female >470ms), ventricular tachycardia, auricular fibrillation, heart block of more than II degrees, myocardial infarction in 1 year, congenital heart disease, with symptomatic coronary heart disease requiring medication.