All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck (Aplus)
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|ClinicalTrials.gov Identifier: NCT04433169|
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : February 2, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Adenoid Cystic Carcinoma of the Head and Neck||Drug: All-trans Retinoic Acid Drug: VEGFR inhibitor Drug: Chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 3, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||June 2023|
Experimental: 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.
Drug: All-trans Retinoic Acid
ATRA 20 mg, three times a day, for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles
Other Name: Ailike
Active Comparator: Control group
The investigator chooses the treatment regimen based on the following regimens (including but not limited to: 1. VEGFR inhibitor; 2. chemotherapy).
Drug: VEGFR inhibitor
- 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.
- Number of Participants With at Least One Grade 3-4 Toxicity [ Time Frame: 6 months ]Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
- Progression-Free Survival [ Time Frame: 6 months ]Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433169
|Contact: Guopei Zhu, M.D||021-23271699 ext email@example.com|
|Shanghai Ninth People's Hospital||Recruiting|
|Shanghai, Shanghai, China, 200011|
|Contact: Lulu Ye, Master 021-23271699 ext 5665 firstname.lastname@example.org|
|Responsible Party:||Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University|
|Other Study ID Numbers:||
|First Posted:||June 16, 2020 Key Record Dates|
|Last Update Posted:||February 2, 2021|
|Last Verified:||June 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type