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Clinical study of romiplostim in the intervention of cancer therapy induced thrombocytopenia

Clinical study of romiplostim in the intervention of cancer therapy induced thrombocytopenia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103356
Enrollment
Unknown
Registered
2025-05-28
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

cancer therapy induced thrombocytopenia

Interventions

Treatment Group:Romiplostim was given subcutaneously once a week at a dose of 3µg/kg.

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old, regardless of gender; 2. CTIT(tumor drug-related thrombocytopenia, platelet count < 100×10^9/L) occurred after treatment of solid tumors, which led to the delay and reduction of chemotherapy; 3. At least 14 days after the last chemotherapy; 4. ECOG PS score 0-2; 5. Understand the study procedure and sign the informed consent form in person.

Exclusion criteria

Exclusion criteria: 1. Malignant tumor with bone marrow metastasis; 2. Patients with hematological malignancies; 3. Hemoglobin concentration below 80g/L after blood transfusion or neutrophil count below 1.0×10^9/L despite administration of granulocyte colony-stimulating factor (long or short acting); 4. Aspartate aminotransferase (AST) greater than 3.0×ULN (no liver metastasis); Aspartate aminotransferase (AST) > 5.0×ULN (liver metastasis); Total bilirubin > 1.5×ULN (no liver metastasis); Total bilirubin > 3.0×ULN (liver metastasis); 5. Deep vein thrombosis or arterial thrombosis within 3 months (except those who were stable and receiving anticoagulant or antiplatelet therapy); 6. It is known to be poorly responsive to TPO receptor agonists; 7. Pregnant or lactating patients; 8. Important organ dysfunction such as liver and kidney failure; 9. Other conditions considered by the investigator to be inappropriate for enrollment.

Design outcomes

Primary

MeasureTime frame
Recovery rate of platelet count;

Secondary

MeasureTime frame
Adverse event incidence rate;

Countries

China

Contacts

Public ContactYe Baodong

The First Affiliated Hospital of Zhejiang Chinese Medical University

13588453501@163.com+86 135 8845 3501

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026