Herombopag for the Prevention of Radio-chemotherapy Induced Thrombocytopenia in Cervical Cancer

Korábbi kezelés

• Participated in clinical trials of any other investigational drug or device within 28 days

Más betegség

• 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
• 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
• known or expected allergy or intolerance to the active ingredient or excipient of hetropopar ethanolamine tablets
• HIV infected
• 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

Laborértékek

• 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

Egyéb

• Bone marrow invasion or metastasis
• Pregnant or lactating women

• 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