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Spots Global Cancer Trial Database for Efficacy and Safety of rhTPO's Prophylactic Treatment of CTIT in Patients With High Risk of Cardiac Injury

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Trial Identification

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

Interventions

rhTPO
Control

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Yunlong Xia, MD,PhD

Affiliation: The First Affiliated Hospital of Dalian Medical University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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