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Romiplostim N01 for the Treatment of Thrombocytopenia Associated With Radiotherapy-Combined Treatment Regimens in Patients With Solid Tumors

NCT07128576 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-04

No results posted yet for this study

Summary

With the development of modern medicine, targeted and immunotherapies have been widely adopted in clinical practice. Beyond conventional chemotherapy combination regimens, the integration of radiotherapy into multimodal treatment strategies has also expanded significantly.

While robust evidence supports the use of romiplostim for managing chemotherapy-induced thrombocytopenia (CIT), there is currently no clinical research evaluating its efficacy in treating thrombocytopenia associated with radiotherapy-combined treatment regimens in solid tumors.

To address this unmet clinical need, this study aims to evaluate the safety and efficacy of romiplostim N01 for injection in the treatment of radiotherapy-combined regimen-induced thrombocytopenia in solid tumor patients. The findings will establish evidence-based management strategies to optimize clinical decision-making in this context.

Conditions

Interventions

DRUG

Romiplostim N01

Romiplostim N01: 3-10 μg/kg(Initial dose 3 μ g/kg), qw, H.

Sponsors & Collaborators

  • Zhujiang Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-08-15
Completion
2028-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07128576 on ClinicalTrials.gov