Nasopharyngeal Carcinoma (NPC)Phase 2NCT07252375
A Clinical Study of Hetrombopag for Prevention of Thrombocytopenia Induced by Gemcitabine Plus Cisplatin in the Treatment of Nasopharyngeal Carcinoma
A Phase 2 study testing herombopag olamine tablets in people with Nasopharyngeal Carcinoma (NPC) and CTIT-Chemotherapy Induced Thrombocytopenia, run by Fujian Cancer Hospital.
Trial summary
This study is a single-arm, exploratory, self-controlled clinical trial for the prevention of thrombocytopenia induced by gemcitabine plus cisplatin in the treatment of nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC), CTIT-Chemotherapy Induced Thrombocytopenia
- What is being tested?
- herombopag olamine tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2025to 30 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- Absolute Neutrophil Count (ANC) > 1.0×10⁹/L, Hemoglobin (Hb) > 80 g/L;
- 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);
- 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);
- 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.
Who cannot join
- 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;
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- 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.
About this study
Official title: A Single-Arm, Exploratory, Self-Controlled Clinical Study of Hetrombopag for Secondary Prevention of Thrombocytopenia Induced by Gemcitabine Plus Cisplatin in the Treatment of Nasopharyngeal Carcinoma
This study is a single-arm, exploratory, self-controlled clinical trial for the prevention of thrombocytopenia induced by gemcitabine plus cisplatin in the treatment of nasopharyngeal carcinoma. It aims to investigate the efficacy and safety of hetrombopag for the secondary prevention of thrombocytopenia caused by gemcitabine plus cisplatin in patients with nasopharyngeal carcinoma. The study protocol has been reviewed and approved by the Institutional Ethics Committee of Fujian Cancer Hospital, allowing the conduct of this clinical study.
- Being tested
- herombopag olamine tablets
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herombopag olamine tabletsDrug
Oral Hetrombopag Olamine Tablets will be initiated at a daily dose of 5 mg (initial dose) on Day 1 (D1) of each chemotherapy cycle, and administered continuously until the start of the next chemotherapy cycle. During the oral administration period, blood routine examinations of subjects will be collected every 3-5 days, and the dosage of hetrombopag will be adjusted according to the Platelet Count (PIT). The dosage adjustment rules are as follows:
When PLT ≥ 100 × 10⁹/L, discontinue administration; When 50 × 10⁹/L ≤ PLT < 100 × 10⁹/L, increase the daily dose by 2.5 mg; When PLT < 50 × 10⁹/L, increase the daily dose by 5 mg; Note: When the platelet count is < 10.0 × 10⁹/L or there is a bleeding risk, rescue measures such as platelet transfusion may be considered based on clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Secondary Prevention Cohort | Experimental | Not described Receives: Drug: herombopag olamine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Grade 3 or Higher Cancer Therapy-Induced Thrombocytopenia (CTIT)
Measured: From the initiation of oral drug administration to 30 days after the last dose of the oral drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start30 Nov 2025 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252375
- Sponsor's protocol ID
- HQBP01
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Exploratory, Self-Controlled Clinical Study of Hetrombopag for Secondary Prevention of Thrombocytopenia Induced by Gemcitabine Plus Cisplatin in the Treatment of Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07252375
- Acronym / sponsor ID
- HQBP01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-arm, exploratory, self-controlled clinical trial for the prevention of thrombocytopenia induced by gemcitabine plus cisplatin in the treatment of nasopharyngeal carcinoma. It aims to investigate the efficacy and safety of hetrombopag for the secondary prevention of thrombocytopenia caused by gemcitabine plus cisplatin in patients with nasopharyngeal carcinoma. The study protocol has been reviewed and approved by the Institutional Ethics Committee of Fujian Cancer Hospital, allowing the conduct of this clinical study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secondary Prevention Cohort | Experimental | Drug: herombopag olamine tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| herombopag olamine tabletsOral Hetrombopag Olamine Tablets will be initiated at a daily dose of 5 mg (initial dose) on Day 1 (D1) of each chemotherapy cycle, and administered continuously until the start of the next chemotherapy cycle. During the oral administration period, blood routine examinations of subjects will be collected every 3-5 days, and the dosage of hetrombopag will be adjusted according to the Platelet Count (PIT). The dosage adjustment rules are as follows: When PLT ≥ 100 × 10⁹/L, discontinue administration; When 50 × 10⁹/L ≤ PLT < 100 × 10⁹/L, increase the daily dose by 2.5 mg; When PLT < 50 × 10⁹/L, increase the daily dose by 5 mg; Note: When the platelet count is < 10.0 × 10⁹/L or there is a bleeding risk, rescue measures such as platelet transfusion may be considered based on clinical practice. | Drug | Secondary Prevention Cohort |
Primary outcome
Incidence Rate of Grade 3 or Higher Cancer Therapy-Induced Thrombocytopenia (CTIT)
Time frame: From the initiation of oral drug administration to 30 days after the last dose of the oral drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing herombopag olamine tablets in people with Nasopharyngeal Carcinoma (NPC) and CTIT-Chemotherapy Induced Thrombocytopenia, run by Fujian Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Rate of Grade 3 or Higher Cancer Therapy-Induced Thrombocytopenia (CTIT) (time frame: From the initiation of oral drug administration to 30 days after the last dose of the oral drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.