A Multicenter, Randomized Controlled Phase II Clinical Study of Hetrombopag Combined With rhTPO in the Treatment of Cancer Therapy-induced Thrombocytopenia (CTIT) in Solid Tumor Patients.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 204
- 主要终点
- Proportion of patients achieving PLT ≥100×10⁹/L or an increase ≥50×10⁹/L from baseline within 14 days of treatment.
研究概览
简要总结
Objective To evaluate the efficacy and safety of hetrombopag plus rhTPO versus hetrombopag monotherapy for CTIT in solid-tumor patients.
Participants 204 histologically- or cytologically-confirmed solid-tumor patients with ≥grade 3 thrombocytopenia following anti-cancer treatment.
Design
Open-label, multicenter, randomized controlled phase II study. Patients are randomized 1:1 into two arms:
Experimental arm (N=102):
rhTPO 15,000 IU/day subcutaneously + hetrombopag 7.5 mg/day orally, both starting on Day 1 for up to 14 days.
Control arm (N=102):
Hetrombopag 7.5 mg/day orally starting on Day 1 for up to 14 days. Stopping & Rescue Rules Stop study drug if PLT ≥100×10⁹/L or rises ≥50×10⁹/L from baseline. If PLT ≤10×10⁹/L or <20×10⁹/L with bleeding risk, give rescue therapy (platelet transfusion or investigator-chosen alternative).
Primary Endpoint Proportion of patients achieving PLT ≥100×10⁹/L or an increase ≥50×10⁹/L from baseline within 14 days of treatment.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years (inclusive), both sexes eligible.
- •Histologically or cytologically confirmed malignant solid tumor (e.g., lung, breast, gastric, colorectal, genitourinary cancers, etc.).
- •Currently receiving anti-cancer therapy: chemotherapy, radiotherapy, immuno-chemotherapy, targeted therapy, or combinations.
- •Grade ≥3 cancer-therapy-induced thrombocytopenia (PLT <50×10⁹/L).
- •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 and not be breastfeeding; they must agree to use effective contraception from enrollment through 7 days after the last study drug. Men with partners of child-bearing potential must be surgically sterilized or agree to use effective contraception during the same period and must not donate sperm.
- •Willing to participate, able to provide written informed consent, and expected to comply with the study protocol.
排除标准
- •Pregnant or breastfeeding women.
- •Individuals unable to understand the nature of the study or who have not given informed consent.
- •History of any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep-vein thrombosis, pulmonary embolism) or clinical/laboratory evidence of a hypercoagulable disorder.
- •Cardiac disease within 3 months before screening: grade 3/4 congestive heart failure, arrhythmia requiring medication, myocardial infarction, conditions predisposing to thrombo-embolism (e.g., atrial fibrillation), or QTc prolongation.
- •Thrombocytopenia attributed to: concurrent chemoradiotherapy, non-anti-cancer therapy, oxaliplatin-induced sinusoidal injury, definite immune-mediated thrombocytopenia, severe bleeding symptoms, refractory persistent thrombocytopenia, or bone-marrow involvement proven by biopsy in patients with bone metastases.
- •Significant hepatic impairment:
- •No liver metastases: ALT/AST > 3 × ULN or TBL > 3 × ULN.
- •Liver metastases present: ALT/AST ≥ 5 × ULN or TBL ≥ 5 × ULN.
- •Known or anticipated hypersensitivity/intolerance to TPO-receptor agonists or any ingredient of hetrombopag ethanolamine tablets.
- •Concomitant use of other agents that may affect platelet count (e.g., traditional Chinese medicines, other thrombopoietic agents, antiplatelet drugs).
- •Receipt of any TPO-receptor agonist (eltrombopag, romiplostim, etc.), recombinant human TPO, or recombinant IL-11 within 1 month before screening.
- •Platelet transfusion within 3 days before randomization/first dose.
- •Any condition that, in the investigator's opinion, renders the patient unsuitable for enrollment.
研究组 & 干预措施
Experimental arm
rhTPO 15,000 IU/day subcutaneously + hetrombopag 7.5 mg/day orally, both starting on Day 1 for up to 14 days.
干预措施: rhTPO + hetrombopag (Drug)
Control arm
Hetrombopag 7.5 mg/day orally starting on Day 1 for up to 14 days.
干预措施: hetrombopag (Drug)
结局指标
主要结局
Proportion of patients achieving PLT ≥100×10⁹/L or an increase ≥50×10⁹/L from baseline within 14 days of treatment.
时间窗: within 14 days of treatment.
次要结局
- Proportion of patients achieving PLT ≥100×10⁹/L or an increase ≥50×10⁹/L from baseline within 7 days Time to PLT recovery to ≥100×10⁹/L Time to PLT increase ≥50×10⁹/L from baseline Lowest (nadir) platelet count recorded Duration of thrombopoietic therapy(within 7 days)
研究者
Shi Yanxia
Professor
Sun Yat-sen University