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

NCT ID: NCT04433169

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-03
• Study Completion Date: 2023-06-30

Brief 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.

Conditions

Adenoid Cystic Carcinoma of the Head and Neck

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

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.

Group Type: EXPERIMENTAL

All-trans Retinoic Acid

Intervention Type: DRUG

ATRA 20 mg, three times a day, for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles

Control group

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

Group Type: ACTIVE_COMPARATOR

VEGFR inhibitor

Intervention Type: DRUG

VEGFR inhibitor

Chemotherapy

Intervention Type: DRUG

chemotherapy

Interventions

All-trans Retinoic Acid

ATRA 20 mg, three times a day, for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles

Intervention Type: DRUG

VEGFR inhibitor

VEGFR inhibitor

Intervention Type: DRUG

Chemotherapy

chemotherapy

Intervention Type: DRUG

Other Intervention Names

Ailike

Eligibility Criteria

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:

1. 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

2. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guopei Zhu, M.D

Role: CONTACT

antica@gmail.com

021-23271699 ext. 5665

Facility Contacts

Lulu Ye, Master

Role: primary

yee166@163.com

021-23271699 ext. 5665

Other Identifiers

2020HNRT02

Identifier Type: -

Identifier Source: org_study_id