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A prospective randomized controlled trial for recombinant human thrombopoietin (rhTPO) at different intervening times to prevent and treat thrombocytopenia after chemotherapy with doxoburicin combined with isocyclophosphamide (AI) regimen in osteosarcoma and soft tissue sarcoma

A prospective randomized controlled trial for recombinant human thrombopoietin (rhTPO) at different intervening times to prevent and treat thrombocytopenia after chemotherapy with doxoburicin combined with isocyclophosphamide (AI) regimen in osteosarcoma and soft tissue sarcoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022667
Enrollment
Unknown
Registered
2019-04-21
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteosarcoma and soft tissue sarcoma

Interventions

A:The patients distributed in group A was treated with rhTPO immediately at a dose of 300 U.d-1.kg-1, ih.
B:The patients distributed in group B continued to observe and check blood every other day. When platelets were found to be less than 75*109/L, rhTPO was administered subcutaneously at a dose of 300 U

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histopathology diagnosed with osteosarcoma or soft tissue sarcoma, and suitable for doxorubicin + isocyclophosphamide treatment; 2. Aged 10 to 70 years, expected survival time >6 months; ECOG:0-1,and amputees could be relaxed to 2 points; 3. Normal bone marrow hematopoietic function(no blood transfusion, no G-CSF, no drug correction within 14 days before screening): 1) ANC=1.5×10^9/L, PLT=100×10^9/L, Hb=90g/L; 2) Cr= 1.5 ULN or CCR= 60 ml/min, TBIL= 1.5 ULN, ALT/AST= 2.5 ULN ( liver metastasis subjects can be relaxed to = 5 ULN); 3) INR= 1.5, PT= 1.5 ULN, APTT = 1.5 ULN; 4) urinary protein 2+), 24-hour urinary protein quantitative display must be (< 1 g); 4. Cardiac function was normal by ECG and echocardiography; 5. Before the start of the study, all patients have been fully understood the research and the must sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Heart function: NYHA score = 2, or LVEF < 50%; 2. Suffering from mental or neurological disorders, can not cooperate; 3. Known allergies to research drugs or any of their excipients; 4. Pregnant or lactating women, or those who plan to become pregnant during the study or within one year after the last use of the drug; 5. The investigator believes that the patient's condition is not suitable for this clinical study.

Design outcomes

Primary

MeasureTime frame
Incidence of grade III/IV thrombocytopenia;

Countries

China

Contacts

Public ContactJing Chen

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

chenjingunion@163.com+86 15807183251

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026