New combo aims to fix Chemo-Caused low platelets
NCT ID NCT07334093
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tests whether combining two platelet-boosting drugs (hetrombopag and rhTPO) works better than hetrombopag alone for cancer patients with dangerously low platelets from treatment. About 204 adults with solid tumors will be randomly assigned to one of the two groups. The goal is to see if more patients reach a safe platelet level within two weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hetrombopag and rhTPO (a platelet-boosting drug combination)
- What this could lead to
- If it works, this could offer a more effective way to raise dangerously low platelet counts in cancer patients, reducing bleeding risks and treatment delays.
- What could go wrong
- This is an early Phase 2 trial with only 204 participants, so results may not apply to all patients. The combination may not work better than the single drug, and there are risks like excessive platelet increases or side effects from the drugs.
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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 204 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 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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Anyone
- 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.
Inclusion Criteria: 1. Age 18-75 years (inclusive), both sexes eligible. 2. Histologically or cytologically confirmed malignant solid tumor (e.g., lung, breast, gastric, colorectal, genitourinary cancers, etc.). 3. Currently receiving anti-cancer therapy: chemotherapy, radiotherapy, immuno-chemotherapy, targeted therapy, or combinations. 4. Grade ≥3 cancer-therapy-induced thrombocytopenia (PLT \<50×10⁹/L). 5. ECOG performance status 0-1. 6. Estimated life expectancy ≥12 weeks. 7. Women of child-bearing potential must have a negative serum pregnancy test within 7 days before first dose and not be breastfeeding; they must agree to use effective contraception from enrollment through 7 days after the last study drug. Men with partners of child-bearing potential must be surgically sterilized or agree to use effective contraception during the same period and must not donate sperm. 8. Willing to participate, able to provide written informed consent, and expected to comply with the study protocol. Exclusion Criteria: 1. Pregnant or breastfeeding women. 2. Individuals unable to understand the nature of the study or who have not given informed consent. 3. History of any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep-vein thrombosis, pulmonary embolism) or clinical/laboratory evidence of a hypercoagulable disorder. 4. Cardiac disease within 3 months before screening: grade 3/4 congestive heart failure, arrhythmia requiring medication, myocardial infarction, conditions predisposing to thrombo-embolism (e.g., atrial fibrillation), or QTc prolongation. 5. Thrombocytopenia attributed to: concurrent chemoradiotherapy, non-anti-cancer therapy, oxaliplatin-induced sinusoidal injury, definite immune-mediated thrombocytopenia, severe bleeding symptoms, refractory persistent thrombocytopenia, or bone-marrow involvement proven by biopsy in patients with bone metastases. 6. Significant hepatic impairment: * No liver metastases: ALT/AST \> 3 × ULN or TBL \> 3 × ULN. * Liver metastases present: ALT/AST ≥ 5 × ULN or TBL ≥ 5 × ULN. 7. Known or anticipated hypersensitivity/intolerance to TPO-receptor agonists or any ingredient of hetrombopag ethanolamine tablets. 8. Concomitant use of other agents that may affect platelet count (e.g., traditional Chinese medicines, other thrombopoietic agents, antiplatelet drugs). 9. Receipt of any TPO-receptor agonist (eltrombopag, romiplostim, etc.), recombinant human TPO, or recombinant IL-11 within 1 month before screening. 10. Platelet transfusion within 3 days before randomization/first dose. 11. Any condition that, in the investigator's opinion, renders the patient unsuitable for enrollment.
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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
Only the study team decides who joins. These are the ways to reach them.
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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
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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