Status:
UNKNOWN
The Efficacy and Safety of Hetrombopag as Secondary Prevention to Chemotherapy-induced Thrombocytopenia in Patients With Gynecologic Malignancies
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Chemotherapy-induced Thrombocytopenia
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
Chemotherapy is an important treatment strategy for gynecological malignancies, such as ovarian cancer, advanced endometrial cancer, cervical cancer. Chemotherapy-induced thrombocytopenia (CIT) is one...
Eligibility Criteria
Inclusion
- Age 18-75 years.
- Pathological diagnosis of gynecological malignancies such as ovarian cancer, cervical cancer, endometrial cancer, etc.
- Grade 2 or above thrombocytopenia occurred after the previous cycle of chemotherapy, and the platelet count recovered to ≥100×109/L through routine clinical intervention.
- Patients plan to receive at least one cycle of chemotherapy containing platinum and paclitaxel.
- Eastern Cooperative Oncology Group Physical Score(ECOG PS) : 0-2.
- Estimated survival≥ 12 weeks.
Exclusion
- Have received pelvic, spinal radiotherapy and bone field irradiation within 3 months before screening.
- Grade I and above thrombocytopenia caused by other diseases within 6 months before screening, including but not limited to chronic liver disease, hypersplenism, infection and bleeding,or hematopoietic system diseases .
- Clinical manifestations of severe bleeding within 2 weeks before screening, including but not limited to gastrointestinal or central nervous system bleeding.
- Abnormal liver function: patients without liver metastases, Alanine aminotransferase（ALT）/aspartate aminotransferase（AST）\>3 upper limit of normal value (ULN); Patients with liver metastases, Alanine aminotransferase（ALT）/aspartate aminotransferase（AST) ≥5 upper limit of normal value (ULN).
- Abnormal renal function: serum creatinine ≥ 1.5upper limit of normal value (ULN).
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06099925
Start Date
October 16 2023
End Date
September 15 2025
Last Update
October 25 2023
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