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New pill may help cancer patients avoid chemo delays due to low platelets

NCT ID NCT07408648

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 244 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Female participants only

Healthy volunteers

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

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

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