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A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia
RecruitingPhase 3
A Randomized, Multi-Center, Double-Blind, Phase III Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.
What is being tested
- Hetrombopag Olamine (drug)
- Hetrombopag Olamine ;Hetrombopag Olamine Placebo (drug)
Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Participants: 150 · Started: Apr 16, 2026
Contact the study team
- Junye Xiong · Phone: 0518-82342973
Official record on ClinicalTrials.gov — NCT07286032
Locations in the U.S.
| California | Cancer and Blood Specialty Clinic, Los Alamitos (Not yet recruiting) |
| Colorado | AdventHealth Hematology and Oncology Denver Cypress Hematology and Oncology, Denver (Not yet recruiting) |
| Florida | Oncology & Hematology Associates of West Broward, Coral Springs (Not yet recruiting) Mid-Florida Hematology & Oncology Centers, P.A., Orange City |
| Illinois | Springfield Clinic, Springfield (Not yet recruiting) |
| New Jersey | Morristown Medical Center, Morristown (Not yet recruiting) |
| New York | New York Cancer and Blood Specialists One Oncology, Shirley (Not yet recruiting) |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.