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
|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.
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 firstname.lastname@example.org|
|Shanghai Ninth People's Hospital||Recruiting|
|Shanghai, Shanghai, China, 200011|
|Contact: Lulu Ye, Master 021-23271699 ext 5665 email@example.com|