Clinical trial · Interventional
Chidamide Combined With Cisplatin in Head and Neck Adenoid Cystic Carcinoma (HNACC)
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
NCT03639168CI-TRIAL-00053408completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoid Cystic Carcinomas | Adenoid Cystic Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cisplatin | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide combined with cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chidamide combined with Cisplatin
- description
- Chidamide: 30mg,PO,biw one week before cycle 1 treatment Cisplatin 25mg/m2 ivgtt D1-3 Chidamide :20mg PO Biw, 2 week on , 1 week off
- interventionNames
- Drug: Chidamide combined with cisplatin
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- 6 weeks
- description
- Defined as numbers of patients achieved complete response and patial response of treatment
Secondary outcomes (3)
- measure
- Disease control rate (DCR)
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.