Desiccated Thyroid Extract Combined With Levothyroxine for TSH Suppression Therapy in DTC
Status:
NOT_YET_RECRUITING
Trial end date:
2028-06-30
Target enrollment:
Participant gender:
Summary
The global incidence of Differentiated Thyroid Cancer (DTC) is rising. While surgery followed by TSH suppression is the standard of care, achieving target TSH levels with levothyroxine (L-T4) monotherapy remains challenging, with only 25-70% of intermediate/high-risk patients attaining it within 6-8 months. This therapeutic dilemma stems from three key issues: impaired T4-to-T3 conversion due to DIO2 polymorphisms, the non-physiological hormone ratio of T4 monotherapy, and L-T4's narrow therapeutic window. This often results in an "under- versus over-suppression" paradox, increasing risks of recurrence, atrial fibrillation, and osteoporosis. Combining L-T4 with desiccated thyroid extract (DTE; T4:T3 4:1) may overcome these limitations by bypassing DIO2 defects and providing a more physiological hormone profile, thereby potentially improving TSH control while mitigating side effects. Supported by the 2023 Chinese guidelines and our promising pilot data (82% cumulative target attainment at a median of 1.4 months), we propose a two-stage national study: a multicenter cohort study followed by a randomized trial, to generate high-level evidence for this combination therapy in high-risk DTC.
Phase:
PHASE3
Details
Lead Sponsor:
West China Hospital
Collaborators:
First Affiliated Hospital of Chongqing Medical University First Affiliated Hospital of Guangxi Medical University First Affiliated Hospital of Kunming Medical University General Hospital of Ningxia Medical University Shang Jin Hospital of West China Hospital,Sichuan University Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China Sir Run Run Shaw Hospital Sun Yat-sen University The Affiliated Hospital Of Guizhou Medical University The Affiliated Hospital of Inner Mongolia Medical University The Fifth People's Hospital of Qinghai Province Qinghai Province Cancer Hospital) The First Affiliated Hospital of Shanxi Medical University The Second Affiliated Hospital of Kunming Medical University The Second Affiliated Hospital of Lanzhou University West China Tianfu Hospital, Sichuan University Xijing Hospital of Airforce Medical University Yantai Yuhuangding Hospital Zhongnan Hospital