A Prospective, Open-label, Randomized Controlled Clinical Study to Evaluate the Efficacy and Safety of All-trans Retinoic Acid (ATRA) in the Treatment of Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck
Overview
- Phase
- Phase 2
- Intervention
- VEGFR inhibitor
- Conditions
- Adenoid Cystic Carcinoma of the Head and Neck
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (CR+PR)
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years, male or female;
- •ECOG PS (performance status) score: 0-1;
- •Pathologically or histologically confirmed advanced, recurrent/metastatic ACC, with measurable disease (≥10 mm by spiral CT scan, meeting RECIST 1.1 criteria);
- •Patients with therapeutic indications;
- •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
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.);
- •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.
Arms & Interventions
Control group
The investigator chooses the treatment regimen based on the following regimens (including but not limited to: 1. VEGFR inhibitor; 2. chemotherapy).
Intervention: VEGFR inhibitor
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.
Intervention: All-trans Retinoic Acid
Control group
The investigator chooses the treatment regimen based on the following regimens (including but not limited to: 1. VEGFR inhibitor; 2. chemotherapy).
Intervention: Chemotherapy
Outcomes
Primary Outcomes
Objective Response Rate (CR+PR)
Time Frame: 6 months
Objective Response Rate as defined by RECIST 1.1 after induction therapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Secondary Outcomes
- Number of Participants With at Least One Grade 3-4 Toxicity(6 months)
- Progression-Free Survival(6 months)