drugset / Trial / NCT05160857

Clinical Study on the Efficacy and Safety of Hetropapa Ethanolamine Tablets in the Treatment of Thrombocytopenia Caused by Concurrent Radiotherapy and Chemotherapy in Cervical Cancer

NCT05160857 ↗

NaSingle-groupOpen-labelTreatment

Summary

This study is a single arm, single center and exploratory clinical study, which aims to explore the efficacy and safety of hetropapa ethanolamine tablets in the treatment of thrombocytopenia caused by concurrent radiotherapy and chemotherapy of cervical cancer. The primary end point was the proportion of subjects who were effective after treatment with hetropapa in the first cycle after treatment, that is, the platelet value recovered to ≥ 100 x 109 / L after treatment. The main inclusion criteria were: voluntary participation in the trial and signing informed consent; Age ≥ 18 years old, regardless of gender; Cervical cancer was diagnosed by histopathology or cytology; Platelet \< 75 × 109/L; At the time of screening, the expected survival time is ≥ 12 weeks, and can be treated with the current chemotherapy regimen for at least 1 cycle.

Timeline

Start
2021-12-31
Primary completion
2022-12-31
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Herombopag Olamine Unknown 7.5 mg Oral

Indications