Chidamide Combined With Cisplatin in Head and Neck Adenoid Cystic Carcinoma (HNACC)
18. august 2021 opdateret af: Kai Xue, MD, Fudan University
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
The investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
22
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 200032
- Kai Xue
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
Chidamide combined with cisplatin
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall response rate (ORR)
Tidsramme: 6 weeks
|
Defined as numbers of patients achieved complete response and patial response of treatment
|
6 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Disease control rate (DCR)
Tidsramme: 6 weeks
|
Defined as numbers of patients achieved complete response, patial response, and stable disease of treatment
|
6 weeks
|
|
Progression-free survival (PFS)
Tidsramme: 6 weeks
|
Defined as the time from randomization until objective tumor progression or death
|
6 weeks
|
|
Scoring of quality of life: EORTC-QLQ-30
Tidsramme: 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.
|
6 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum ctDNA biomarker
Tidsramme: throughout the treatment period，up to 6 months
|
relationship between biomarker and treatment outcome
|
throughout the treatment period，up to 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kai Xue, MD, Department of medical oncology,Fudan University, Shanghai Cancer Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. juni 2018
Primær færdiggørelse (Faktiske)
24. juni 2020
Studieafslutning (Faktiske)
2. juni 2021
Datoer for studieregistrering
Først indsendt
4. august 2018
Først indsendt, der opfyldte QC-kriterier
16. august 2018
Først opslået (Faktiske)
21. august 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. august 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. august 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CC-HN-1
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .