A Clinical Study on the Efficacy and Safety of Hetrombopag in the Treatment of Thrombocytopenia Induced by Gynecological Tumor Therapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 244
- 主要终点
- Proportion of subjects achieving a treatment response
研究概览
简要总结
The study consists of five sequential periods:
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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.
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Key eligibility criteria:
- •Female, aged 18-75 years (inclusive).
- •Histopathologically or cytologically confirmed ovarian, cervical, endometrial, or other gynecologic malignancy.
- •Thrombocytopenia (platelet count < 75 × 10⁹/L) attributable to anti-cancer therapy, with ≥ 2 further treatment cycles planned.
- •ECOG performance status 0-
- •Estimated life expectancy ≥ 12 weeks.
- •Women of child-bearing potential must have a negative serum pregnancy test within 7 days before first dose, not be breastfeeding, and agree to use effective contraception from study entry through 7 days after the last dose.
- •Able to provide written informed consent and comply with study procedures.
排除标准
- •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-
- •Platelet transfusion within 3 days before randomisation/first dose.
- •Any condition that, in the investigator's opinion, renders the patient unsuitable for the study.
研究组 & 干预措施
Correction phase: start hetrombopag 7.5 mg orally once daily and continue until platelet count norma
干预措施: hetrombopag 7.5 mg orally once daily (Drug)
Correction phase: initiate hetrombopag 7.5 mg orally once daily and continue until platelet count re
干预措施: hetrombopag 7.5 mg orally once daily (Drug)
结局指标
主要结局
Proportion of subjects achieving a treatment response
时间窗: 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.
次要结局
未报告次要终点
研究者
Lu Huaiwu
Department of Gynecological,Sun Yat-sen Memorial Hospital of Sun Yat-sen Uniwersity,Guangzhou,China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University