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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 2

Conditions: Adenoid Cystic Carcinoma of the Head and Neck

Treatments: Drug: All-trans Retinoic Acid; Drug: VEGFR inhibitor; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04433169

2020HNRT02

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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:

2. Criteria for routine blood test: (no blood transfusion within 14 days)

   1. HB ≥ 90 g/L;
   2. WBC ≥ 3.5 × 109/L and < 10 × 109/L;
   3. ANC ≥ 1.5 × 109/L;
   4. PLT ≥ 80 × 109/L

3. Criteria for biochemical tests:

   1. BIL < 1.25 × upper limit of normal (ULN)
   2. ALT and AST < 2.5 × ULN; in the presence of metastases to liver, ALT and AST < 5 × ULN;
   3. 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

1. Previous or existing concomitant malignancies except cured skin basal cell carcinoma or cervical carcinoma in situ;
2. Coagulation abnormal (INR>1.5, APTT>1.5×ULN), 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];
3. Confirmed hypersensitivity to ATRA;
4. Grade I and above coronary artery diseases, arrhythmias [including QTc prolongation (males: > 450 ms, females: > 470 ms)] and cardiac dysfunction;
5. Presence of multiple factors affecting oral administration (e.g. dysphagia, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
6. Pregnant or lactating women;
7. History of psychotropic abuse with abstinence failure, or existing mental disorder;
8. Participation in other drug clinical trials within 4 weeks;
9. Other concomitant diseases which seriously jeopardize the patient's safety or prevent the patient from completing the study, as judged by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental group

Experimental group

Description:

ATRA 20 mg, three times a day (tid), for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles; combined with the treatment regimen chosen by the investigator since Day 6 of cycle 1.

Treatment:

Drug: All-trans Retinoic Acid

Control group

Active Comparator group

Description:

The investigator chooses the treatment regimen based on the following regimens (including but not limited to: 1. VEGFR inhibitor; 2. chemotherapy).

Treatment:

Drug: Chemotherapy

Drug: VEGFR inhibitor