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

Phase 2

Completed

• Conditions: Cisplatin; Adenoid Cystic Carcinomas
• Interventions: Drug: Chidamide combined with cisplatin

• Registration Number: NCT03639168
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

Adenoid cystic carcinomas (ACCs) constitute of 1% of head and neck cancers. This type of tumor grows slowly with a high potential of local recurrence. Approximately 50% of patients develop distant metastases, and 33% patients die within 2 years. The initial therapy of these malignancies consists of surgical resection followed by radiotherapy. Systemic therapy is crucial in the management of recurrent and metastatic disease. However, nowadays, there were no standard chemoimmunotherapy regimes. Previous report showed that overall response rate was only less than 10% using single-agent chemotherapies, and the best results were achieved by cisplatin. Chidamide is a new benzamide class of histone deacetylase inhibitor with marked antitumor activity. And a phase I study has showed that one of three patients with submandibular adenoid cystic carcinoma achieved a partial response treated with Chidamide. The investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma, in order to find a potential promising way to treat this kind of disease.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-06-06
• Study First Submitted: 2018-08-04
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-21
• Primary Completion: 2020-06-24
• Study Completion: 2021-06-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chidamide combined with Cisplatin	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

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	6 weeks	Defined as numbers of patients achieved complete response and patial response of treatment

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	6 weeks	Defined as numbers of patients achieved complete response, patial response, and stable disease of treatment
Progression-free survival (PFS)	6 weeks	Defined as the time from randomization until objective tumor progression or death
Scoring of quality of life: EORTC-QLQ-30	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.

Trial Locations

Locations (1)

Kai Xue; 🇨🇳 Shanghai, Shanghai, China