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

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · Dec 17, 2024

Keywords

ClinConnect Summary

The clinical trial titled "Herombopag for the Prevention of Radio-chemotherapy Induced Thrombocytopenia in Cervical Cancer" is investigating a medication called herombopag to see if it can help prevent low platelet counts (thrombocytopenia) that can occur when women with cervical cancer undergo radiation and chemotherapy. Low platelet counts can lead to bleeding and other complications, so finding effective ways to manage this side effect is important for patient safety and treatment success.

To participate in this trial, women aged 18 and older with confirmed cervical cancer, who are receiving specific chemotherapy treatments, may be eligible. Participants will need to sign consent forms and meet certain health criteria, such as having expected survival of at least 12 weeks and no recent severe health issues. If eligible, participants can expect to receive the study medication while being closely monitored for its effects on their platelet counts and overall health. This trial is currently not recruiting participants, but it aims to provide valuable information on how to better manage treatment side effects in cervical cancer patients.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Volunteer to participate in the trial and sign the informed consent
• • 2. Pathologically or cytologically confirmed cervical cancer
• • 3. aged 18 years or older
• • 4. ECOG performance score 0-1
• • 5. Stage IB3-IVA according to 2018 FIGO stage
• • 6. 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)
• • 7. Survival expected to be ≥12 weeks, and can be treated with the concurrent chemotherapy regimen for at least one cycle
• • 8. 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
• • 9. Participants can be treated with thrombopoietic drugs determined by researchers
• Exclusion Criteria:
• • 1. Participants with other diseases of hematopoietic system, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome
• • 2. 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
• • 3. Bone marrow invasion or metastasis
• • 4. 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
• • 5. History of any arterial or venous thrombosis within the last 6 months
• • 6. Severe bleeding within 2 weeks, such as gastrointestinal or central nervous system bleeding, vaginal bleeding, etc
• • 7. Neutrophil absolute value \<1.5×109/L, hemoglobin \<80g/L, PLT\<90× 109/L
• • 8. 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
• • 9. Abnormal renal function: serum creatinine ≥1.5ULN or eGFR≤60 ml/min(Cockcroft-Gault formula)
• • 10. Had received platelet infusion within 3 days
• • 11. known or expected allergy or intolerance to the active ingredient or excipient of hetropopar ethanolamine tablets
• • 12. HIV infected
• • 13. Pregnant or lactating women
• • 14. Participated in clinical trials of any other investigational drug or device within 28 days
• • 15. Inability to swallow, inflammatory bowel disease, or uncontrollable nausea, vomiting, diarrhea, or other gastrointestinal disorders that severely affect the administration and absorption of medications
• • 16. With a high risk for participants' safety or other conditions that may affect the efficacy evaluated by investigators