Chemotherapy Induced ThrombocytopeniaPhase 2NCT07408648
A Clinical Study on the Efficacy and Safety of Hetrombopag in the Treatment of Thrombocytopenia Induced by Gynecological Tumor Therapy
A Phase 2 study testing hetrombopag 7.5 mg orally once daily in people with Chemotherapy Induced Thrombocytopenia, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
The study consists of five sequential periods: Screening (≤ 4 weeks) Correction phase Maintenance phase (first treatment cycle, Cycle 1) Observation phase (second treatment cycle, Cycle 2) Follow-up Eligible subjects are gynaecological-cancer patients who developed ≥ grade-2 cancer-therapy-induced thrombocytopenia… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Chemotherapy Induced Thrombocytopenia
- What is being tested?
- hetrombopag 7.5 mg orally once daily
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 30 Jun 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnant or lactating women.
- Unable to understand the study nature or give informed consent.
- History of any arterial or venous thrombosis (stroke, TIA, MI, DVT, PE) or clinical/laboratory evidence of thrombophilia.
- 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.
- Thrombocytopenia not related to anti-cancer therapy, active severe bleeding, or refractory persistent thrombocytopenia.
- Significant hepatic impairment:
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- No liver metastases: ALT/AST > 3 × ULN or TBL > 3 × ULN
- Liver metastases: ALT/AST ≥ 5 × ULN or TBL ≥ 5 × ULN
- Known or suspected hypersensitivity/intolerance to TPO-receptor agonists or hetrombopag excipients.
- Concomitant use of agents that may affect platelet count (e.g., Chinese herbal medicines, other thrombopoietic agents, antiplatelet drugs).
- Receipt within 1 month before screening of TPO-RAs (eltrombopag, romiplostim, etc.), rhTPO, or rhIL-11.
- Platelet transfusion within 3 days before randomisation/first dose.
- Any condition that, in the investigator's opinion, renders the patient unsuitable for the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Huaiwu Lu contact
About this study
The study consists of five sequential periods:
- Screening (≤ 4 weeks)
- Correction phase
- Maintenance phase (first treatment cycle, Cycle 1)
- Observation phase (second treatment cycle, Cycle 2)
- Follow-up Eligible subjects are gynaecological-cancer patients who developed ≥ grade-2 cancer-therapy-induced thrombocytopenia (CTIT) after anti-tumour therapy, i.e. platelet count < 75 × 10⁹/L.
- Stage 1 - Prospective, multicentre, randomised clinical study (to inform the confirmatory stage 2) Cohort 1 (n = 30)** Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹/L. Within 24 h after completion of Cycle 1 anti-cancer therapy (end of chemotherapy if combined; otherwise end of investigational product on that day) restart hetrombopag 7.5 mg p.o. daily and continue until the last day of Cycle 1 (C1D21).
Read more
Cohort 2 (n = 30) Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹/L. During Cycle 1, monitor PLT closely; if PLT falls < 75 × 10⁹/L, initiate hetrombopag 7.5 mg p.o. daily and continue until C1D21.
Stage 2 - Prospective, multicentre, randomised, controlled clinical study *(preliminary design; sample size and details will be refined after stage-1 results)* Experimental arm (n = 92) Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹/L. Restart within 24 h after completion of Cycle 1 therapy and continue daily until C1D21.
Control arm (n = 92) Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹/L. During Cycle 1, monitor PLT; if PLT < 75 × 10⁹/L, initiate hetrombopag 7.5 mg p.o. daily until C1D21.
Correction-phase rules Discontinue hetrombopag once PLT ≥ 100 × 10⁹/L. If after ≥ 14 days of hetrombopag correction PLT remains < 100 × 10⁹/L and the next treatment cycle has not started, the investigator may resume hetrombopag or institute alternative platelet-enhancing rescue therapy at their discretion.
- Conditions
- Chemotherapy Induced Thrombocytopenia
- Being tested
- hetrombopag 7.5 mg orally once daily
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hetrombopag 7.5 mg orally once dailyDrug
Correction phase: start hetrombopag 7.5 mg orally once daily and continue until platelet count normalizes (PLT ≥ 100 × 10⁹/L).
Within 24 h after completion of Cycle 1 anti-cancer therapy-defined as the end of chemotherapy infusion if on a combined regimen, or the end of study drug administration on that day for non-chemotherapy regimens-restart hetrombopag 7.5 mg orally once daily and maintain until the last day of Cycle 1 (C1D21).
| Study group | Role | What they receive |
|---|---|---|
| Correction phase: start hetrombopag 7.5 mg orally once daily and continue until platelet count norma | Experimental | Not described Receives: Drug: hetrombopag 7.5 mg orally once daily |
| Correction phase: initiate hetrombopag 7.5 mg orally once daily and continue until platelet count re | Other | Not described Receives: Drug: hetrombopag 7.5 mg orally once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving a treatment response
Treatment-response criteria (all must be met):
- Completed the entire first treatment cycle (Cycle 1) with a platelet count ≥ 100 × 10⁹/L at C1D21 (window: +4 days).
- Received no rescue therapy for thrombocytopenia (e.g., platelet transfusion, rhIL-11, rhTPO) from the start of Cycle 1 through C1D21 (window: +4 days).
- Had no Cycle 2 modifications attributable to CTIT: no delay ≥ 4 days, no dose reduction ≥ 15 %, and no treatment suspension.
Measured: At the end of the first cycle (each cycle is 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Huaiwu, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Huaiwu Lu, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408648
- Sponsor's protocol ID
- SYSKY-2025-1015-01
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Efficacy and Safety of Hetrombopag in the Treatment of Thrombocytopenia Induced by Gynecological Tumor Therapy
- ClinicalTrials.gov ID
- NCT07408648
- Acronym / sponsor ID
- SYSKY-2025-1015-01
- Conditions
- Chemotherapy Induced Thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Feb 2026 (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.
The study consists of five sequential periods:
- Screening (≤ 4 weeks)
- Correction phase
- Maintenance phase (first treatment cycle, Cycle 1)
- Observation phase (second treatment cycle, Cycle 2)
- Follow-up Eligible subjects are gynaecological-cancer patients who developed ≥ grade-2 cancer-therapy-induced thrombocytopenia (CTIT) after anti-tumour therapy, i.e. platelet count < 75 × 10⁹/L.
- Stage 1 - Prospective, multicentre, randomised clinical study (to inform the confirmatory stage 2) Cohort 1 (n = 30)** Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹/L. Within 24 h after completion of Cycle 1 anti-cancer therapy (end of chemotherapy if combined; otherwise end of investigational product on that day) restart hetrombopag 7.5 mg p.o. daily and continue until the last day of Cycle 1 (C1D21).
Cohort 2 (n = 30) Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹/L. During Cycle 1, monitor PLT closely; if PLT falls < 75 × 10⁹/L, initiate hetrombopag 7.5 mg p.o. daily and continue until C1D21.
Stage 2 - Prospective, multicentre, randomised, controlled clinical study *(preliminary design; sample size and details will be refined after stage-1 results)* Experimental arm (n = 92) Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹/L. Restart within 24 h after completion of Cycle 1 therapy and continue daily until C1D21.
Control arm (n = 92) Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹/L. During Cycle 1, monitor PLT; if PLT < 75 × 10⁹/L, initiate hetrombopag 7.5 mg p.o. daily until C1D21.
Correction-phase rules Discontinue hetrombopag once PLT ≥ 100 × 10⁹/L. If after ≥ 14 days of hetrombopag correction PLT remains < 100 × 10⁹/L and the next treatment cycle has not started, the investigator may resume hetrombopag or institute alternative platelet-enhancing rescue therapy at their discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Correction phase: start hetrombopag 7.5 mg orally once daily and continue until platelet count norma | Experimental | Drug: hetrombopag 7.5 mg orally once daily |
| Correction phase: initiate hetrombopag 7.5 mg orally once daily and continue until platelet count re | Other | Drug: hetrombopag 7.5 mg orally once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Pregnant or lactating women.
- Unable to understand the study nature or give informed consent.
- History of any arterial or venous thrombosis (stroke, TIA, MI, DVT, PE) or clinical/laboratory evidence of thrombophilia.
- 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.
- Thrombocytopenia not related to anti-cancer therapy, active severe bleeding, or refractory persistent thrombocytopenia.
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 |
|---|---|---|
| hetrombopag 7.5 mg orally once dailyCorrection phase: start hetrombopag 7.5 mg orally once daily and continue until platelet count normalizes (PLT ≥ 100 × 10⁹/L). Within 24 h after completion of Cycle 1 anti-cancer therapy-defined as the end of chemotherapy infusion if on a combined regimen, or the end of study drug administration on that day for non-chemotherapy regimens-restart hetrombopag 7.5 mg orally once daily and maintain until the last day of Cycle 1 (C1D21). | Drug | Correction phase: initiate hetrombopag 7.5 mg orally once daily and continue until platelet count re, Correction phase: start hetrombopag 7.5 mg orally once daily and continue until platelet count norma |
Primary outcome
Proportion of subjects achieving a treatment response
Time frame: At the end of the first cycle (each cycle is 28 days).
Treatment-response criteria (all must be met): 1. Completed the entire first treatment cycle (Cycle 1) with a platelet count ≥ 100 × 10⁹/L at C1D21 (window: +4 days). 2. Received no rescue therapy for thrombocytopenia (e.g., platelet transfusion, rhIL-11, rhTPO) from the start of Cycle 1 through C1D21 (window: +4 days). 3. Had no Cycle 2 modifications attributable to CTIT: no delay ≥ 4 days, no dose reduction ≥ 15 %, and no treatment suspension.
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 13 Feb 2026.
- 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.
Huaiwu Lu contact
Huaiwu Lu principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hetrombopag 7.5 mg orally once daily in people with Chemotherapy Induced Thrombocytopenia, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 0 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 13 Feb 2026. 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?
Contact Huaiwu Lu (02081332587, luhuaiwu@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving a treatment response (time frame: At the end of the first cycle (each cycle is 28 days).). 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 13 Feb 2026.