Status:
UNKNOWN
All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck
Lead Sponsor:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions:
Adenoid Cystic Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 metastati...
Eligibility Criteria
Inclusion
- 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:
- 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
- Previous or existing concomitant malignancies except cured skin basal cell carcinoma or cervical carcinoma in situ;
- Coagulation abnormal (INR\>1.5, APTT\>1.5×ULN), history of gastrointestinal hemorrhage in the past 6 months or bleeding tendency \[e.g., presence of active ulcer focus in the stomach, stool occult blood (++), melena and/or hematemesis, hemoptysis in the past 3 months\];
- 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.
Key Trial Info
Start Date :
June 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04433169
Start Date
June 3 2020
End Date
June 1 2023
Last Update
February 2 2021
Active Locations (1)
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1
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China, 200011