A real-world study on the efficacy and safety of roprestine N01 in the treatment of thrombocytopenia caused by concurrent/sequential chemoradiotherapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600128509

Enrollment

Unknown

Registered

2026-07-21

Start date

2026-07-21

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

thrombocytopenia related to malignant tumor treatment

Interventions

Treatment group:Roppstein

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in the trial and sign the informed consent form; 2. Age 18 or older, any gender; 3. Diagnosed with a malignant tumor by pathological tissue or cytology examination; 4. Currently undergoing concurrent/sequential chemoradiotherapy, using one or more chemotherapy drugs; 5. Platelets <75×10^9/L, and after one week of treatment with TPO agonist, platelets are still below 25×10^9/L; 6. Willing to join this study, sign the informed consent form, and have good compliance.

Exclusion criteria

Exclusion criteria: 1. People with other hematologic diseases besides chemotherapy-induced thrombocytopenia (CIT), including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndromes; 2. Those who had thrombocytopenia caused by reasons other than CIT within 6 months before screening, including but not limited to chronic liver disease, hypersplenism, infections, or bleeding; 3. Those who received treatment with thrombopoietin receptor agonists (like eltrombopag or avatrombopag) within 1 month before screening; 4. Those who had platelet transfusions within 14 days before enrollment; 5. Patients known or expected to be allergic or intolerant to the active ingredient or excipients of Luspatercept N01; 6. Pregnant or breastfeeding women; 7. Any other situations where the investigator thinks participating in the trial carries significant health or safety risks to the subject, or could affect efficacy evaluation.

Design outcomes

Primary

Measure	Time frame
platelet number;	—

Secondary

Measure	Time frame
coagulation function test;	—

Countries

China

Contacts

Public ContactTian Le

Cancer Hospital Chinese Academy of Medical Sciences

tianle511@163.com+86 10 87788527

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026