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New drug aims to stop chemo side effect in nose and throat cancer

NCT ID NCT07252375

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

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

Participants

About 35 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

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.

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

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How to take part

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  1. The official record

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