Hetrombopag versus placebo for chemotherapy-related low platelets

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares hetrombopag olamine tablets with placebo in adults who develop chemotherapy-induced thrombocytopenia while on 21-day platinum- or gemcitabine-containing regimens. Participants receive either hetrombopag or placebo and are monitored for platelet counts, bleeding events, need for transfusion or chemotherapy delays, and adverse effects. Eligible patients have histologically or cytologically confirmed solid tumors, ECOG performance status 0–2, and a life expectancy of at least six months. Safety and efficacy will be tracked over subsequent chemotherapy cycles to determine whether hetrombopag improves platelet recovery without unacceptable toxicity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female, 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 14- or 21-day treatment cycles.
4. Platelet count \< 85 x 109/L at enrollment.
5. For Part B, experiencing a chemotherapy delay of ≥ 7 days due to CIT.
6. At least 2 scheduled chemotherapy cycles of the same treatment regimen as was used prior to enrollment.
7. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
8. Life expectancy ≥6 months.
9. Signed ICF for voluntary participation in the study and good compliance.

Exclusion Criteria:

1. WHO Grade ≥ 2 bleeding within 14 days prior to screening.
2. Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
3. Hematologic malignancies.
4. 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.
5. Untreated brain metastases; or with leptomeningeal metastasis.
6. Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
7. Severe cardiovascular disorders or interventions within 6 months.
8. Have arterial/venous thrombosis with anticoagulation not tolerated for at least 6 weeks.
9. Known bleeding disorders, platelet dysfunction.
10. Severe haemorrhage during screening (e.g., gastrointestinal or intracranial hemorrhage) within 28 days prior to enrolment.
11. Previous treatment with thrombopoietin receptor agonists (TPO-RAs) within 14 days prior to enrolment.
12. Platelet transfusion within 72 hours prior to enrollment.
13. Acute or uncontrolled hepatitis B\&C infection.
14. Human immunodeficiency virus (HIV) infection.

Where it's running

• Cancer and Blood Specialty Clinic
  Los Alamitos, California, United States Recruiting
• UCLA
  Los Angeles, California, United States Recruiting
• Clermont Oncology Center
  Clermont, Florida, United States Recruiting
• Oncology & Hematology Associates of West Broward
  Coral Springs, Florida, United States Recruiting
• Mid-Florida Hematology & Oncology Centers, P.A.
  Orange City, Florida, United States Recruiting
• Springfield Clinic
  Springfield, Illinois, United States Recruiting

+1 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Brian Yu, MD
• Email: brian.yu@hengrui.com
• Phone: +86 400 828 3900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.