CompletedPhase 2

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

China22 participantsStarted 2018-06-06

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age range 18-75 years old
✓. Histological confirmed recurrent or metastatic head and neck adenoid cystic carcinoma
✓. Unable to treat with surgery/radiotherapy, or previously failure to non-cisplatin systematic treatment;
✓. Eastern Cooperative Oncology Group performance status 0 to 2;
✓. Patients have written informed consent to participate in the study;
✓. anticipated to live ≧3 months;
✓. Absolute neutrophil count ≥ 1.5×109/L，platelet ≥ 100×109/L，hemoglobin ≥ 90 g/L
✓. total bilirubin \< 1.5×upper limit of normal(ULN), ALT and AST \< 3× ULN

Exclusion criteria

✕. Previously treated with HDACi;
✕. Treated with cisplatin-contained regimes in the past half of the year, and not achieving PR/CR;
✕. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;
✕. HIV, HCV, or syphilis infection；
✕. Pregnant or lactating women;
✕. Serious uncontrolled infection;
✕. Severe neurol of mental illness, including dementia and epilepsy;
✕. Having contraindications to the use of oral medication, such as unable to swallow, nausea and vomiting, chronic diarrhea or suffering from a bowel obstruction;

What they're measuring

Overall response rate (ORR)

Timeframe: 6 weeks

Trial details

NCT IDNCT03639168

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-24

View on ClinicalTrials.gov More Adenoid Cystic Carcinomas trials