NCT07286032PHASE3Recruiting
A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia
Jiangsu HengRui Medicine Co., Ltd.
Start Date
4/16/2026
Completion Date
6/1/2029
Summary
The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
1. Male or female gender, age ≥18 years at screening.
2. Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma \[NSCLC\], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
3. Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
5. Life expectancy ≥6 months.
6. Signed ICF for voluntary participation in the study and good compliance.
Exclusion Criteria:
1. Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
2. Hematologic malignancies.
3. Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months prior to Study Day 1.
4. Untreated brain metastases; or with leptomeningeal metastasis.
5. Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
6. Severe cardiovascular disorders or interventions within 6 months
7. Have arterial/venous thrombosis within 6 months
8. Known bleeding disorders, platelet dysfunction
9. Severe haemorrhage during screening
10. Acute or uncontrolled hepatitis B\&C infection
11. Human immunodeficiency virus (HIV) infection.
Interventions
DRUG
Hetrombopag Olamine
DRUG
Hetrombopag Olamine ;Hetrombopag Olamine Placebo
Conditions
Patients With Chemotherapy-Induced Thrombocytopenia
Locations
Cancer and Blood Specialty Clinic
Los Alamitos, California 90254
United States
AdventHealth Hematology and Oncology Denver Cypress Hematology and Oncology
Denver, Colorado 80210
United States
Oncology & Hematology Associates of West Broward
Coral Springs, Florida 33065
United States
Mid-Florida Hematology & Oncology Centers, P.A.
Orange City, Florida 32763
United States
Springfield Clinic
Springfield, Illinois 62702
United States
Morristown Medical Center
Morristown, New Jersey 07039
United States
New York Cancer and Blood Specialists One Oncology
Shirley, New York 11967
United States