Cisplatin Clinical Trial
Official title:
Chidamide Combined With Cisplatin in Recurrent or Metastatic Head and Neck Adenoid Cystic Carcinoma: A Prospective, Open-label, Phase II Study of a Single Center
NCT number | NCT03639168 |
Other study ID # | CC-HN-1 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 6, 2018 |
Est. completion date | June 2, 2021 |
Verified date | August 2021 |
Source | Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma.
Status | Completed |
Enrollment | 22 |
Est. completion date | June 2, 2021 |
Est. primary completion date | June 24, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Kai Xue | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Serum ctDNA biomarker | relationship between biomarker and treatment outcome | throughout the treatment period,up to 6 months | |
Primary | Overall response rate (ORR) | Defined as numbers of patients achieved complete response and patial response of treatment | 6 weeks | |
Secondary | Disease control rate (DCR) | Defined as numbers of patients achieved complete response, patial response, and stable disease of treatment | 6 weeks | |
Secondary | Progression-free survival (PFS) | Defined as the time from randomization until objective tumor progression or death | 6 weeks | |
Secondary | Scoring of quality of life: EORTC-QLQ-30 | Quality of life was evaluated using EORTC-QLQ-30. All subscales are summed to compute a total score, and total scores are recorded. Lower scores represent a better outcome. | 6 weeks |
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