Hetrombopag versus placebo for chemotherapy-related low platelets

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

This trial tests whether hetrombopag tablets can raise platelet counts and reduce bleeding in adults who develop low platelets from platinum- or gemcitabine-based chemotherapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 7 sites (Los Alamitos, California and 6 other locations)
• Trial ID: NCT07286032 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with confirmed solid tumors receiving platinum- or gemcitabine-based 21-day chemotherapy cycles who develop chemotherapy-induced thrombocytopenia, with ECOG 0–2 and life expectancy ≥6 months would be ideal candidates.

Not a fit: Patients whose thrombocytopenia is due to other causes (for example chronic liver disease, hypersplenism, infection), those with hematologic malignancies, or with untreated brain/leptomeningeal metastases are unlikely to benefit from this treatment.

Why it matters

Potential benefit: If successful, hetrombopag could reduce bleeding, transfusion needs, and chemotherapy interruptions by helping platelet counts recover faster.

How similar studies have performed: Other thrombopoietin-receptor agonists (such as eltrombopag and avatrombopag) have raised platelet counts in some chemotherapy settings, but large-scale phase 3 evidence specifically for chemotherapy-induced thrombocytopenia is limited and results have been mixed.

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.

Where this trial is running

Los Alamitos, California and 6 other locations

• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States (Not_yet_recruiting)
• AdventHealth Hematology and Oncology Denver Cypress Hematology and Oncology — Denver, Colorado, United States (Not_yet_recruiting)
• Oncology & Hematology Associates of West Broward — Coral Springs, Florida, United States (Not_yet_recruiting)
• Mid-Florida Hematology & Oncology Centers, P.A. — Orange City, Florida, United States (Recruiting)
• Springfield Clinic — Springfield, Illinois, United States (Not_yet_recruiting)
• Morristown Medical Center — Morristown, New Jersey, United States (Not_yet_recruiting)
• New York Cancer and Blood Specialists One Oncology — Shirley, New York, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Junye Xiong

Conditions Patients With Chemotherapy-Induced Thrombocytopenia