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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

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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