New drug aims to stop chemo side effect in nose and throat cancer
NCT ID NCT07252375
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether the drug hetrombopag can prevent severe low platelet counts caused by chemotherapy in people with nasopharyngeal carcinoma. About 35 patients who already had low platelets during a previous chemo cycle will take hetrombopag tablets daily during their next two cycles. The goal is to see if this reduces the risk of dangerous bleeding and helps patients stay on schedule with their cancer treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hetrombopag olamine tablets
- What this could lead to
- If it works, this could help nasopharyngeal carcinoma patients avoid dangerous drops in platelets during chemotherapy, allowing them to complete their treatment as planned.
- What could go wrong
- This is a small, early-phase trial with only 35 participants and no comparison group, so results may not apply broadly. The drug may not prevent low platelets effectively or could cause side effects.
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
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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 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2025
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Aged 18 to 75 years old, regardless of gender; * 2\. Patients with nasopharyngeal carcinoma confirmed by pathological or cytological examination; * 3\. Currently receiving treatment with the Gemcitabine + Cisplatin (GP) regimen at a 21-day cycle, with the lowest platelet count \< 75×10⁹/L in the previous chemotherapy cycle, and expected to maintain the same chemotherapy regimen for at least 2 more cycles; * 4\. Estimated survival time ≥ 12 weeks; * 5\. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2; * 6\. Laboratory test indicators meeting the following requirements: 1. Absolute Neutrophil Count (ANC) \> 1.0×10⁹/L, Hemoglobin (Hb) \> 80 g/L; 2. Renal function: Creatinine (Cr) ≤ 1.5 × Upper Limit of Normal (ULN) or estimated Glomerular Filtration Rate (eGFR) ≥ 60 ml/min (calculated by the Cockcroft-Gault formula); 3. Liver function: Total Bilirubin (TBIL) ≤ 1.5 × ULN; Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × ULN; (If the patient has intrahepatic cholangiocarcinoma or liver metastasis, total bilirubin ≤ 3 × ULN and transaminases ≤ 5 × ULN); 4. Coagulation function: International Normalized Ratio (INR) of Prothrombin Time (PT) ≤ 1.5 × ULN, and Activated Partial Thromboplastin Time (APTT) within the normal range; * 7\. Females of childbearing potential must agree to use contraception during the study and for 6 months after the study ends; non-lactating females are eligible. Males must agree to use contraception during the study and for 6 months after the study ends; * 8\. No participation in other clinical trials of drugs within 4 weeks prior to enrollment; * 9\. Subjects must understand the study details and voluntarily sign the Informed Consent Form (ICF); * 10\. No severe complications such as active massive gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, or non-cancerous fever \> 38℃; * 11\. Expected to have good compliance and be able to complete follow-up for efficacy and adverse reactions as required by the protocol. Exclusion Criteria: * 1\. Thrombocytopenia not caused by cancer therapy occurring within 6 months prior to screening, including but not limited to hepatic cirrhosis with hypersplenism, infection, and bleeding; * 2\. Having other hematopoietic system diseases besides chemotherapy-induced thrombocytopenia, including leukemia, primary immune thrombocytopenia (ITP), myeloproliferative diseases (MPDs), multiple myeloma (MM), myelodysplastic syndromes (MDS), etc.; * 3\. Complicated with bone marrow involvement or bone marrow metastasis; * 4\. Having received pelvic, spinal radiotherapy or large-field bone irradiation within 3 months prior to screening; * 5\. History of any arterial or venous thrombosis occurring within 6 months prior to screening; * 6\. Clinical manifestations of severe bleeding (such as gastrointestinal bleeding) within 2 weeks prior to screening; * 7\. Severe cardiovascular diseases (e.g., NYHA Cardiac Function Classification Grade III-IV) within 6 months prior to screening, or patients with arrhythmias known to increase thromboembolic risk (such as atrial fibrillation \[AF\]), history of coronary artery stenting, angioplasty, or coronary artery bypass grafting (CABG); * 8\. Brain tumor or brain metastasis; * 9\. Having received platelet transfusion within 2 days prior to enrollment; * 10\. Having received treatment with recombinant human thrombopoietin (rhTPO), recombinant human interleukin-11 (rhIL-11), or thrombopoietin receptor agonist drugs (such as eltrombopag, avatrombopag) within 5 days prior to screening; * 11\. Patients with known or anticipated allergy or intolerance to the active ingredient or excipients of Hetrombopag Ethanolamine Tablets (excipients include: cellulose-lactose, low-substituted hydroxypropyl cellulose \[L-HPC\], magnesium stearate, film-coating premix); * 12\. Pregnant or lactating women; * 13\. Patients deemed ineligible for enrollment by the investigator.
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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