A Clinical Study on the Efficacy and Safety of Hetrombopag in the Treatment of Thrombocytopenia Induced by Gynecological Tumor Therapy

NCT07408648 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SYSKY-2025-1015-01
• Study Type: interventional
• Target: 244
• Locations: 0 countries
• Sites: N/A

Brief 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 (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.

Conditions

Chemotherapy Induced Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving a treatment response

  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.

  At the end of the first cycle (each cycle is 28 days).

Study Arms (2)

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

Interventions

hetrombopag 7.5 mg orally once daily DRUG

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).

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Interventions

hetrombopag

Study Officials

• Huaiwu Lu

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huaiwu Lu

CONTACT

02081332587; luhuaiwu@mail.sysu.edu.cn

Huaiwu Lu

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Gynecological,Sun Yat-sen Memorial Hospital of Sun Yat-sen Uniwersity,Guangzhou,China

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 13, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share