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

Обзор

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.

Вмешательства

• Препарат hetrombopag 7.5 mg orally once daily
  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).

Первичные конечные точки

• Proportion of subjects achieving a treatment response [Срок оценки: At the end of the first cycle (each cycle is 28 days).]

Критерии участия

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 0-1.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07408648 · SYSKY-2025-1015-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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