All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck

STATUS

Recruiting
participants needed

30
sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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Updated on 19 February 2024

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blood transfusion

ct scan

measurable disease

metastasis

liver metastasis

carcinoma

spiral computed tomography

blood test

liver metastases

tretinoin

metastatic adenoid cystic carcinoma

Summary

This is a prospective, open-label, randomized controlled clinical intervention study to evaluate the efficacy and safety of all-trans retinoic acid (ATRA) in treating patients with recurrent metastatic adenoid cystic carcinoma of the head and neck.

Details

Condition	Adenoid Cystic Carcinoma of the Head and Neck
Age	18-100 years
Treatment	Chemotherapy, All-trans Retinoic Acid, VEGFR inhibitor
Clinical Study Identifier	NCT04433169
Sponsor	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age 18 years, male or female; 2. ECOG PS (performance status) score: 0-1; 3. Pathologically or histologically confirmed advanced, recurrent/metastatic ACC, with measurable disease (10 mm by spiral CT scan, meeting RECIST 1.1 criteria); 4. Patients with therapeutic indications; 5. Main organ functions normal, i.e., meeting the criteria
	below
	Criteria for routine blood test: (no blood transfusion within 14 days)
	HB 90 g/L
	WBC 3.5 109/L and < 10 109/L
	ANC 1.5 109/L
	PLT 80 109/L
	Criteria for biochemical tests
	BIL < 1.25 upper limit of normal (ULN)
	ALT and AST < 2.5 ULN; in the presence of metastases to liver, ALT and AST < 5 ULN
	Serum Cr 1 ULN, endogenous creatinine clearance > 50 mL/min (Cockcroft-Gault equation); 5. Subjects who volunteer to participate in this study, sign the informed consent, have good compliance and cooperate in follow-up; 6. Patients who, in the doctor's opinion, can benefit from the treatment
Exclusion Criteria
	Previous or existing concomitant malignancies except cured skin basal cell carcinoma or cervical carcinoma in situ
	Coagulation abnormal (INR>1.5, APTT>1.5ULN), history of gastrointestinal hemorrhage in the past 6 months or bleeding tendency [e.g., presence of active ulcer focus in the stomach, stool occult blood (++), melena and/or hematemesis, hemoptysis in the past 3 months]
	Confirmed hypersensitivity to ATRA
	Grade I and above coronary artery diseases, arrhythmias [including QTc prolongation (males: > 450 ms, females: > 470 ms)] and cardiac dysfunction
	Presence of multiple factors affecting oral administration (e.g. dysphagia, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.)
	Pregnant or lactating women
	History of psychotropic abuse with abstinence failure, or existing mental disorder
	Participation in other drug clinical trials within 4 weeks
	Other concomitant diseases which seriously jeopardize the patient's safety or prevent the patient from completing the study, as judged by the investigator

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All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck