New pill may help cancer patients avoid chemo delays due to low platelets
NCT ID NCT07408648
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a daily pill called hetrombopag to see if it can safely raise low platelet counts in women with gynecological cancers (like ovarian or cervical cancer) after chemotherapy. About 244 women whose platelets dropped too low will take the drug to help them complete their next chemo cycle on time and at full dose. The goal is to reduce the need for platelet transfusions and keep cancer treatment on track.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 244 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key eligibility criteria: 1. Female, aged 18-75 years (inclusive). 2. Histopathologically or cytologically confirmed ovarian, cervical, endometrial, or other gynecologic malignancy. 3. Thrombocytopenia (platelet count \< 75 × 10⁹/L) attributable to anti-cancer therapy, with ≥ 2 further treatment cycles planned. 4. ECOG performance status 0-1. 5. Estimated life expectancy ≥ 12 weeks. 6. Women of child-bearing potential must have a negative serum pregnancy test within 7 days before first dose, not be breastfeeding, and agree to use effective contraception from study entry through 7 days after the last dose. 7. Able to provide written informed consent and comply with study procedures. Exclusion criteria: 1. Pregnant or lactating women. 2. Unable to understand the study nature or give informed consent. 3. History of any arterial or venous thrombosis (stroke, TIA, MI, DVT, PE) or clinical/laboratory evidence of thrombophilia. 4. Cardiac disease within 3 months before screening: NYHA class III/IV heart failure, symptomatic arrhythmia requiring therapy, MI, arrhythmias increasing thrombotic risk (e.g., atrial fibrillation), or QTc prolongation. 5. Thrombocytopenia not related to anti-cancer therapy, active severe bleeding, or refractory persistent thrombocytopenia. 6. Significant hepatic impairment: * No liver metastases: ALT/AST \> 3 × ULN or TBL \> 3 × ULN * Liver metastases: ALT/AST ≥ 5 × ULN or TBL ≥ 5 × ULN 7. Known or suspected hypersensitivity/intolerance to TPO-receptor agonists or hetrombopag excipients. 8. Concomitant use of agents that may affect platelet count (e.g., Chinese herbal medicines, other thrombopoietic agents, antiplatelet drugs). 9. Receipt within 1 month before screening of TPO-RAs (eltrombopag, romiplostim, etc.), rhTPO, or rhIL-11. 10. Platelet transfusion within 3 days before randomisation/first dose. 11. Any condition that, in the investigator's opinion, renders the patient unsuitable for the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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