Efficacy and Safety of rhTPO's Prophylactic Treatment of CTIT in Patients With High Risk of Cardiac Injury

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.

Conditions

• Cancer Treatment Induced Thrombocytopenia

Interventions

DRUG

rhTPO

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.

DRUG

Control

Non-rhTPO treatment

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• Anqing Municipal Hospital

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Peking University Shougang Hospital

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Shaanxi Provincial Cancer Hospital

  collaborator OTHER

• Beijing Sanhuan Cancer Hospital

  collaborator UNKNOWN

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

  collaborator OTHER

• Bethune Charitable Foundation

  collaborator UNKNOWN

• The First Affiliated Hospital of Dalian Medical University

  lead OTHER

Principal Investigators

• Yunlong Xia, MD,PhD · The First Affiliated Hospital of Dalian Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-06

Primary Completion

2024-06-30

Completion

2024-08-31

Countries

• China

Study Locations