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Brief Title: Efficacy and Safety of rhTPO's Prophylactic Treatment of CTIT in Patients With High Risk of Cardiac Injury
Official Title: A Multicenter Randomized Controlled Study to Assess the Efficacy and Safety of rhTPO's Prophylactic Treatment of Cancer Treatment-induced Thrombocytopenia in Patients With High Risk of Treatment-induced Cardiac Injury
Study ID: NCT05411705
Brief Summary: To assess the efficacy and safety of an optimised dosing regimen of rhTPO's prophylactic treatment of cancer treatment-induced thrombocytopenia(CTIT) and to explore the cardioprotective effect of rhTPO in cancer patients with high risk of treatment-induced cardiac injury.
Detailed Description: This is an open-label prospective randomized multicenter study of rhTPO's prophylactic treatment of CTIT in patients receiving chemotherapy at high risk of cardiac injury. Adult cancer patients with high risk of cancer treatment-induced thrombocytopenia and cardiac injury were enrolled. Patients will be randomised into the rhTPO treatment group or non-rhTPO treatment group with a 2:1 ratio. The patients in rhTPO group will receive rhTPO 300U/kg/d subcutaneous injection for 5 days per cycle and total 3 cycles. The primary endpoint is to observe the improvement of platelet count by rhTPO during 3 cycles treatment period.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Anqing Municipal Hospital, Anqing, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Beijing Chaoyang District Sanhuan Cancer Hospital, Beijing, Beijing, China
Peking University Shougang Hospital, Beijing, Beijing, China
Chinese PLA General Hospital, Beijing, Beijing, China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Henan Provincial People's Hospital, Zhengzhou, Henan, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Union Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Tongji Hospital Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei, China
Affiliated Tumor Hospital of Nantong University, Nanyang, Jiangsu, China
The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
Shaanxi Provincial Cancer Hospital, Xi'an, Shaanxi, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
Name: Yunlong Xia, MD,PhD
Affiliation: The First Affiliated Hospital of Dalian Medical University
Role: PRINCIPAL_INVESTIGATOR