Herombopag for the Prevention of Radio-chemotherapy Induced Thrombocytopenia in Cervical Cancer: A Single-arm Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of participants with PLT <75×109/L after the use of herombopag
研究概览
简要总结
Exploring and evaluating the efficacy of herombopag in preventing thrombocytopenia due to radiotherapy for cervical cancer
详细描述
Thrombocytopenia is a relatively common adverse effect for cancer treatment. At present, for the secondary prevention of thrombocytopenia associated with tumor therapy, TPO-RA drugs have been included in the Level III recommendation of the "Thrombocytopenia Diagnosis and Treatment Guidelines for Cancer Treatment (2022 Edition)".
Herombopag, a new generation of thrombopoietin receptor agonist, is a Class 1 innovative drug independently developed in China, which has been approved in June 2021 for the indication of chronic primary immune thrombocytopenia with poor response to previous treatments of glucocorticoids and immunoglobulins, as well as severe aplastic anemia with poor efficacy of immunosuppressive treatments. As an oral medication, this drug is more convenient and safer than traditional injectable preparations. However, this drug has not been formally approved for the treatment of therapy-related thrombocytopenia.
This study is planned to enroll cervical cancer patients with thrombocytopenia due to radiotherapy combined with a three-week regimen of chemotherapy, and to evaluate the efficacy of herombopag in preventing thrombocytopenia in this group of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in the trial and sign the informed consent
- •Pathologically or cytologically confirmed cervical cancer
- •aged 18 years or older
- •ECOG performance score 0-1
- •Stage IB3-IVA according to 2018 FIGO stage
- •Patients receiving cisplatin-contained two-drug every-three week chemotherapy; minimum PLT value of the last chemotherapy <50×109/L, or ≥50 ×109/L, but <75×109/L, meeting at least one high risk factor for bleeding: previous bleeding history; receiving cisplatin, gemcitabine, cytarabiine, anthracycline chemotherapy; combination of targeting or chemotherapy drugs likely to cause thrombocytopenia; tumor bone marrow infiltration; receiving radiotherapy, such as long bone or flat bone (pelvic or sternum)
- •Survival expected to be ≥12 weeks, and can be treated with the concurrent chemotherapy regimen for at least one cycle
- •Participants of reproductive age who agree to use reliable contraceptive methods throughout the study period (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive paste, contraceptive suppository, abstinence from sex, and insertion of an IUD); Female subjects who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation or more than 1 year postmenopausal and male subjects who have undergone bilateral vasectomy or ligation are excluded
- •Participants can be treated with thrombopoietic drugs determined by researchers
排除标准
- •Participants with other diseases of hematopoietic system, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome
- •Participants with thrombocytopenia occurred within the last 6 months due to causes other than CTIT, including but not limited to chronic liver disease, hypersplenism, infection
- •Bone marrow invasion or metastasis
- •History of severe cardiovascular disease within the last 6 months, such as congestive heart failure (NYHA heart function score III-IV), arrhythmias known to increase the risk of thromboembolism such as atrial fibrillation, after coronary stenting, angioplasty, and para-coronary transplantation, etc
- •History of any arterial or venous thrombosis within the last 6 months
- •Severe bleeding within 2 weeks, such as gastrointestinal or central nervous system bleeding, vaginal bleeding, etc
- •Neutrophil absolute value <1.5×109/L, hemoglobin <80g/L, PLT<90× 109/L
- •Significantly abnormal liver function :TBIL>1.5ULN(upper limit of normal), >3ULN for patients known to have Gilbert syndrome; ALT>2.5ULN or AST>2.5ULN
- •Abnormal renal function: serum creatinine ≥1.5ULN or eGFR≤60 ml/min(Cockcroft-Gault formula)
- •Had received platelet infusion within 3 days
- •known or expected allergy or intolerance to the active ingredient or excipient of hetropopar ethanolamine tablets
- •HIV infected
- •Pregnant or lactating women
- •Participated in clinical trials of any other investigational drug or device within 28 days
- •Inability to swallow, inflammatory bowel disease, or uncontrollable nausea, vomiting, diarrhea, or other gastrointestinal disorders that severely affect the administration and absorption of medications
- •With a high risk for participants' safety or other conditions that may affect the efficacy evaluated by investigators
研究组 & 干预措施
Herombopag
Cervical cancer patients who developed thrombopenia after receiving radiotherapy and platinum-based chemotherapy were enrolled
干预措施: herombopag (Drug)
结局指标
主要结局
Proportion of participants with PLT <75×109/L after the use of herombopag
时间窗: Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
number of participants with PLT \<75×109/L/ all participants
次要结局
- minimum value of platelet after chemotherapy(Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy)
- Change from baseline in PLT count minimum value(Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy)
- Median duration of PLT <75×109/L(Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy)
- Median time to recovery of PLT to ≥100×109/L(Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy)
- Platelet count one day before the next chemotherapy(Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy)
- Incidence of reduced intensity of next cycle chemotherapy due to decreased PLT(Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy)
研究者
xiaofanli
MD.
Peking University Cancer Hospital & Institute