The Efficacy and Safety of Hetrombopag as Secondary Prevention to Chemotherapy-induced Thrombocytopenia in Patients With Gynecologic Malignancies

Chemotherapy-induced Thrombocytopenia Clinical Trial

Official title:

The Efficacy and Safety of Hetrombopag as Secondary Prevention to Chemotherapy-induced Thrombocytopenia in Patients With Gynecologic Malignancies（the SPRIT TRIAL）

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06099925
• Other study ID #: SYSKY-2023-842-02
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 16, 2023
• Est. completion date: September 15, 2025

Study information

• Verified date: October 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: miaofang Wu
• Phone: +8613828494674
• Email: wmiaofang[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: September 15, 2025
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chemotherapy-induced Thrombocytopenia
• Thrombocytopenia

Intervention

Drug:
• Hetrombopag
All the recruited 48 patients will take hetrombopag 5mg/day within 24 hours after chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of hetrombopag	incidence of thrombocytopenia according to Common Terminology Criteria for Adverse Events 5.0(CTCAE5.0)	from the date of recruitment to the time of 14 days
Secondary	reduction of dose	the percentage of dose reduction due to thrombocytopenia	from the date of recruitment to the time of 3 weeks
Secondary	adverse reactions	Incidence of adverse reactions	from the date of recruitment to the time of 3 weeks