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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
165
rhTPO 300U/kg/d QD, subcutaneous injection applied for 5 days per cycle, total 3 cycles. If the patient's platelet count showed a trend of continuous decline and/or was accompanied by the risk of bleeding during the treatment or after the completion of 5 doses of rhTPO, the investigator judged that rhTPO should be continued for treatment, and rhTPO could be administered subcutaneously at 300U/kg/ day for a maximum of 14 doses per cycle. Discontinue when the absolute platelet count increases by ≥50×10\^9/L or when the platelet count rises to ≥250×10\^9/L.
Non-rhTPO treatment
Anqing Municipal Hospital
Anqing, Anhui, China
RECRUITINGProportion of patients whose platelet count is ≥ 75×10^9/L after 2 cycles cancer treatment.
Efficacy was defined as treatment without salvage therapy to increase platelet counts.
Time frame: After 2 cycles cancer treatment (month 1.5~month 2, depends on chemotherapy regimen), each cycle is 14, 21 or 28 days
Proportion of patients receiving salvage treatment to increase platelet counts.
Salvage treatment including platelet infusion, rhIL-11, etc.
Time frame: during 3 cycles cancer treatment period(each cycle is 14, 21 or 28 days)
Changes in cTnT/cTnI
Time frame: 1 and 3 months after initial treatment
Changes in NT-proBNP
Time frame: 1 and 3 months after initial treatment
Changes in LVEF
LVEF will be assessed by echocardiography
Time frame: 1 and 3 months after initial treatment
Changes in neutrophile granulocyte count
Time frame: during 3 cycles cancer treatment period(each cycle is 14, 21 or 28 days)
Incidence of adverse events
treatment-related adverse events
Time frame: from study start date to the end of follow-up, up to 3 months
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Chaoyang District Sanhuan Cancer Hospital
Beijing, Beijing Municipality, China
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RECRUITINGThe Fourth Hospital of Hebei Medical University
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NOT_YET_RECRUITINGHenan Provincial People's Hospital
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Zhengzhou, Henan, China
RECRUITINGUnion Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGTongji Hospital Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
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