NCT07578064招募中4 期
A Randomized, Self-controlled Post-marketing Clinical Study on the Comparison of Shengbai Oral Liquid and Leucogen Tablets in the Treatment of Moderate Neutropenia Caused by Anti-tumor Drugs in Breast Cancer Patients
Hongxia Wang1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月6日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
The subjects were randomly assigned to Group A or Group B in a 1:1 ratio, stratified by early/late stage. Group A: In the first cycle, they took Shengbai Oral Liquid (40 ml, three times a day), and in the second cycle, they took Leucogen Tablets (20 mg, three times a day). Group B: In the first cycle, they took Leucogen Tablets (20 mg, three times a day), and in the second cycle, they took Shengbai Oral Liquid (40 ml, three times a day).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age range: 18 to 80 years old, gender unrestricted;
- •Patients with breast cancer confirmed by histopathology.
- •ECOG performance status score ≤ 2; expected survival time ≥ 12 weeks;
- •During the period of anti-tumor drug treatment before enrollment (including but not limited to chemotherapy drugs: paclitaxel, capecitabine, vinorelbine; CDK4/6 inhibitors: palbociclib, dalpiciclib, ribociclib, abemaciclib; antibody-drug conjugates: trastuzumab emtansine, trastuzumab deruxtecan, sacituzumab govitecan, larotrectinib), grade II-III neutropenia occurred, and it is planned to continue the original treatment plan and dose for at least 2 cycles.
- •The subject meets the criteria for continuing anti-tumor drug treatment; normal bone marrow hematopoietic function, no bleeding tendency (INR < 1.5); blood routine meets the following requirements: Hb ≥ 8g/dl, platelet count ≥ 75×109/L; liver and kidney function meets the following requirements: AST and ALT ≤ 3 ULN, total bilirubin ≤ 2 ULN, serum creatinine ≤ 1.5 ULN; no obvious heart and lung function disorders;
- •The subject has high compliance and voluntarily signs the informed consent form.
排除标准
- •1. Having participated in other new drug clinical trials within 4 weeks before enrollment; planning to participate in other new drug clinical trials during the study period; planning to add other anti-tumor treatments during the study period;
- •Having received bone marrow radiotherapy involving 25% of the bone marrow; having undergone hematopoietic stem cell transplantation or bone marrow transplantation;
- •Uncontrolled acute or chronic infection; having severe underlying diseases such as heart, lung, liver or kidney diseases; having primary diseases of the hematopoietic system; having diseases such as hypersplenism, hyperthyroidism, adrenal insufficiency, connective tissue diseases, etc. that can cause a decrease in white blood cells;
- •Uncontrolled digestive system symptoms that affect the administration of the study drug; confirmed or suspected allergy to the study drug or its related components;
- •Uncontrolled psychological or mental disorders; judged by the investigator as unsuitable for participation in this study.
研究者
Hongxia Wang
Director
Fudan University
研究点 (1)
Loading locations...
相似试验
已完成
Unknown
A study to check the safety of a tablet that contains Calcium Aspartate, Magnesium Hydroxide, and Vitamin D3, given to people who have low levels of calcium and vitamin D.CTRI/2025/07/091843OVERSEAS HEALTH CARE PVT LTD.200
尚未招募
4 期
To compare the visual outcomes between EYECRYL lens and RAYNER EMV/HOYA IOL in cataract surgery patientsCTRI/2024/06/068297BIOTECH VISION CARE PVT LTD30
进行中（未招募）
不适用
A Real-world Study on the Treatment of Adult B-cell Acute Lymphoblastic Leukemia With CNCT-19NCT07269587Ruijin Hospital275
招募中
Unknown
A two arm, Assessor blind, clinical study to evaluate safety and efficacy of an antimicrobial wound dressing (VELVERT®) in comparison to a non-silver dressing in treatment of diabetic foot ulcer.CTRI/2024/10/075593Datt Mediproducts Pvt Ltd,56
已完成
Unknown
Milk Of Magnesia+Liquid Paraffin+Sodium Picosulfate In The Management Of Constipation Post Ano-Rectal Surgery PatientsCTRI/2024/07/070750Abbott India Limited80