Clinical 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tumor Chemotherapy-related Thrombocytopenia
Lead sponsor: Second Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Voluntarily participate in the trial and sign the informed consent form; 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

Exclusion Criteria:

* Screening or baseline platelet value \< 30 × 109/L Suffering from the following hematopoietic system diseases other than thrombocytopenia (CIT) caused by tumor chemotherapy drugs, including but not limited to leukemia, primary immune thrombocytopenia, bone marrow proliferative diseases, multiple myeloma and myelodysplastic syndrome; Thrombocytopenia caused by causes other than CIT occurred within 6 months before screening, including but not limited to chronic liver disease, hypersplenism, infection and bleeding; Clinical manifestations of severe bleeding within 2 weeks before screening, such as gastrointestinal tract or central nervous system bleeding; Neutrophil absolute value \< 1.0 × 109 / L, hemoglobin \< 80g / L; It is allowed to use granulocyte colony stimulating factor, erythrocyte and EPO infusion in line with clinical routine; The researcher believes that participating in the trial has a great risk to the subject's health or safety, or other situations that may affect the efficacy evaluation.

Primary outcomes:
measure: Platelet index
timeFrame: Blood routine tests were conducted every three days within 14 days after taking the drug
Secondary outcomes:
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: The second hospital of Shanxi Medical University
state: Shanxi
Study officials:
References: