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Trial Title:
The Efficacy and Safety of Hetrombopag as Secondary Prevention to Chemotherapy-induced Thrombocytopenia in Patients With Gynecologic Malignancies
NCT ID:
NCT06099925
Condition:
Chemotherapy-induced Thrombocytopenia
Conditions: Official terms:
Thrombocytopenia
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Hetrombopag
Description:
All the recruited 48 patients will take hetrombopag 5mg/day within 24 hours after
chemotherapy
Arm group label:
Hetrombopag
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 of the most common chemotherapy-related hematologic
toxicities and can increase the risk of bleeding, prolong hospital stays, increase
healthcare costs, and, in severe cases, death. It can lead to a reduction in the
intensity of chemotherapy doses, delay the next cycle of chemotherapy, or even
termination of treatment, thereby affecting the antitumor effect and adversely affecting
the long-term survival of these patients. Literature and our data show that when patients
develop grade II or worse CIT, the incidence of grade II and above CIT after the next
cycle of chemotherapy is 85-92%. Hetrombopag is one of the thrombopoietin receptor
agonist (TPO-RA) that has been studied to explore its role in the treatment and
prevention of CIT in multiple solid tumors. In order to find out the secondary prevention
efficacy of CIT, it is planned to carry out this single-arm prospective study by
recruiting 48 patients with gynecological malignancies with grade II CIT or above after
chemotherapy, whose platelets has returned to normal after the routine clinical
intervention, and then plan to have the next cycle of chemotherapy. The intervention
strategy is taking hetrombopag 5mg/day within 24 hours after chemotherapy, then observe
the incidence rate of grade II CIT. The endpoint of this study is to assess the
effectiveness and safety of hetrombopag for preventing CIT in patients with
gynaecological malignancies.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75 years.
2. Pathological diagnosis of gynecological malignancies such as ovarian cancer,
cervical cancer, endometrial cancer, etc.
3. 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.
4. Patients plan to receive at least one cycle of chemotherapy containing platinum and
paclitaxel.
5. Eastern Cooperative Oncology Group Physical Score(ECOG PS) : 0-2.
6. Estimated survival≥ 12 weeks.
Exclusion Criteria:
1. Have received pelvic, spinal radiotherapy and bone field irradiation within 3 months
before screening.
2. 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 .
3. Clinical manifestations of severe bleeding within 2 weeks before screening,
including but not limited to gastrointestinal or central nervous system bleeding.
4. 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).
5. Abnormal renal function: serum creatinine ≥ 1.5upper limit of normal value (ULN).
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
October 16, 2023
Completion date:
September 15, 2025
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06099925
