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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective Response Rate (CR+PR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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);
- •Subjects who volunteer to participate in this study, sign the informed consent, have good compliance and cooperate in follow-up;
- •Patients who, in the doctor's opinion, can benefit from the treatment.
排除标准
- •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.
研究组 & 干预措施
Control group
The investigator chooses the treatment regimen based on the following regimens (including but not limited to: 1. VEGFR inhibitor; 2. chemotherapy).
干预措施: VEGFR inhibitor (Drug)
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.
干预措施: All-trans Retinoic Acid (Drug)
Control group
The investigator chooses the treatment regimen based on the following regimens (including but not limited to: 1. VEGFR inhibitor; 2. chemotherapy).
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Objective Response Rate (CR+PR)
时间窗: 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.
次要结局
- Number of Participants With at Least One Grade 3-4 Toxicity(6 months)
- Progression-Free Survival(6 months)