Chidamide Combined With Cisplatin in Head and Neck Adenoid Cystic Carcinoma (HNACC)
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ClinicalTrials.gov Identifier: NCT03639168 |
Recruitment Status :
Completed
First Posted : August 21, 2018
Last Update Posted : August 19, 2021
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Condition or disease | Intervention/treatment | Phase |
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Adenoid Cystic Carcinomas Cisplatin | Drug: Chidamide combined with cisplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | June 6, 2018 |
Actual Primary Completion Date : | June 24, 2020 |
Actual Study Completion Date : | June 2, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Chidamide combined with Cisplatin
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
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Drug: Chidamide combined with cisplatin
Chidamide combined with cisplatin |
- Overall response rate (ORR) [ Time Frame: 6 weeks ]Defined as numbers of patients achieved complete response and patial response of treatment
- Disease control rate (DCR) [ Time Frame: 6 weeks ]Defined as numbers of patients achieved complete response, patial response, and stable disease of treatment
- Progression-free survival (PFS) [ Time Frame: 6 weeks ]Defined as the time from randomization until objective tumor progression or death
- Scoring of quality of life: EORTC-QLQ-30 [ Time Frame: 6 weeks ]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.
- Serum ctDNA biomarker [ Time Frame: throughout the treatment period,up to 6 months ]relationship between biomarker and treatment outcome

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- serum creatine <1.5×ULN, and creatinine clearance rate (CCR) ≥ 50 ml/min
- Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed no signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
- 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:
- 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;
- Participated in other clinical trials in 4 weeks;
- Other coexisting diseases or situations that may cause patients to fail to complete clinical trials;
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639168
China, Shanghai | |
Kai Xue | |
Shanghai, Shanghai, China, 200032 |
Principal Investigator: | Kai Xue, MD | Department of medical oncology,Fudan University, Shanghai Cancer Center |
Responsible Party: | Kai Xue, MD, Clinical Professor, Fudan University |
ClinicalTrials.gov Identifier: | NCT03639168 |
Other Study ID Numbers: |
CC-HN-1 |
First Posted: | August 21, 2018 Key Record Dates |
Last Update Posted: | August 19, 2021 |
Last Verified: | August 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Carcinoma, Adenoid Cystic Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Adenocarcinoma Cisplatin Antineoplastic Agents |