A Multicenter, Randomized, Self-controlled Exploratory Clinical Study of Hetrombopag Olamine Tablets for Thrombocytopenia Induced by Anti-tumor Treatment in Advanced Breast Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study now plans to explore the efficacy and safety of hetrombopag in cancer therapy-induced thrombocytopenia in advanced breast cancer, so as to further guide the clinical application of hetrombopag in chemotherapy-induced platelets.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• The patients signed the informed consent and voluntarily joined the study;

• Age 18-75 years old, male or female;

• Patients with advanced breast cancer diagnosed by histopathology or cytology, who are receiving and continue to receive the same chemotherapy regimen;

• Can accept the current chemotherapy regimen (must be platinum-containing chemotherapy regimen: lobaplatin, carboplatin, cisplatin, etc.) for at least 2 cycles;

• The first occurrence of platelets \<50×109/L in the current chemotherapy cycle;

• The investigator determines that the patient can receive hetrombopag administration;

• Neutrophil count ≥ 1.0×109/L, hemoglobin ≥ 80g/L before administration of Haitrombopag;

• Life expectancy at screening ≥ 12 weeks;

• ECOG: 0-1;

⁃ The main organ functions are normal, and there are no serious complications.

Locations
Other Locations
China
Henan Cancer Hospital
RECRUITING
Zhengzhou
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
min yan
ym200678@126.com
15713857388
Time Frame
Start Date: 2022-08-19
Estimated Completion Date: 2025-08-01
Participants
Target number of participants: 60
Treatments
Experimental: hetrombopag Olamine tablets
The first anti-tumor treatment cycle (multicenter, open label, randomized controlled):~When platelets were \<50\*109/L, oral hetrombopag 7.5 mg/day was started. When the platelet count is \>100\*109/L, the administration is suspended.~2nd anti-tumor treatment cycle (exploratory study): Prophylactic use (60 cases in the test group and the control group): oral hetrombopag 7.5 mg/day (initial dose) was started on d2 after anti-tumor treatment for 14 days.
Other: rhTPO
The first anti-tumor treatment cycle (multicenter, open label, randomized controlled):~Start using rh-TPO 15000 units/day (subcutaneous injection) when platelets are less than 50\*109/L. When the platelet count is more than 100\*109/L, the administration is suspended.~2nd anti-tumor treatment cycle (exploratory study): Prophylactic use (60 cases in the test group and the control group): oral hetrombopag 7.5 mg/day (initial dose) was started on d2 after anti-tumor treatment for 14 days.
Related Therapeutic Areas
Sponsors
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Leads: Henan Cancer Hospital

This content was sourced from clinicaltrials.gov

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