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
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).
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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.
- 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
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- 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