All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma … (NCT04433169) | Clinical Trial Compass
UnknownPhase 2
All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck
China30 participantsStarted 2020-06-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. Previous or existing concomitant malignancies except cured skin basal cell carcinoma or cervical carcinoma in situ;
✕. Coagulation abnormal (INR\>1.5, APTT\>1.5×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.);
What they're measuring
1
Objective Response Rate (CR+PR)
Timeframe: 6 months
Trial details
NCT IDNCT04433169
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University