NCT07492693招募中2 期
Exploring the Efficacy and Safety of Hetrombopag in Preventing Chemotherapy-induced Thrombocytopenia in Gastrointestinal Tumors
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The proportion of patients with a platelet count >75×10⁹/L on day 14 (D14)
研究概览
简要总结
This trial is a single-arm, prospective clinical study aimed at evaluating the efficacy and safety of hetrombopag in preventing chemotherapy-induced thrombocytopenia (CIT) in patients with gastrointestinal tumors. The study plans to enroll 40 patients with gastrointestinal tumors who develop thrombocytopenia due to chemotherapy. Patients who meet the inclusion and exclusion criteria will maintain the same treatment regimen and dosage as the previous cycle (N-1 cycle). On the day of chemotherapy in the current cycle (N cycle), they will take hetrombopag (D1) at 7.5 mg/day orally for 14 consecutive days on an empty stomach, and may eat two hours after administration, avoiding taking it with meals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years;
- •pathologically confirmed gastrointestinal tumors (including esophageal cancer, gastric cancer, colorectal cancer, etc.);
- •during the previous chemotherapy cycle (N-1 cycle), patients had a minimum platelet count of ≥75×10⁹/L and at least one high-risk bleeding factor (① history of bleeding; ② previous treatment with platinum agents, gemcitabine, cytarabine, anthracyclines, etc.; ③ tumor cell bone marrow infiltration; ④ previous or ongoing radiotherapy, especially to long bones or flat bones such as the pelvis or sternum);
- •during the current chemotherapy cycle (N cycle), patients have a platelet count of ≥100±25×10⁹/L;
- •undergoing treatment cycles of 14 or 21 days and requiring at least one more cycle of therapy.
- •ECOG score: 0-2 points;
- •Adequate hematopoietic, liver, and kidney function:
- •Neutrophil count ≥ 1.5 x 10⁹/L
- •Hemoglobin ≥ 9.0 g/dL
- •Creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)
- •For patients without liver metastasis, AST and ALT ≤ 2.5 times the upper limit of normal;
- •Bilirubin ≤ 2 times the upper limit of normal;
- •APTT and PT ≤ 1.5 times the upper limit of normal
- •Signed informed consent form.
排除标准
- •Previous use of TPO-RA drugs;
- •Pre-treatment conditions that cause thrombocytopenia, such as hypersplenism or immune thrombocytopenia;
- •History of thrombosis;
- •Hematologic diseases (anemia, leukemia, autoimmune hemolytic diseases, etc.);
- •Major cardiovascular diseases (acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, etc.);
- •Pregnant or breastfeeding women;
- •Participation in other drug clinical trials within 4 weeks;
- •Poor compliance, unable to cooperate or report treatment responses;
- •Need for other antiplatelet or platelet-enhancing drugs, including traditional Chinese medicine and herbal preparations;
- •Use of prior platelet-stimulating drugs within 5 half-lives before first dose;
- •Platelet transfusion within 3 days before first dose.
结局指标
主要结局
The proportion of patients with a platelet count >75×10⁹/L on day 14 (D14)
时间窗: From enrollment to the end of treatment at 2 weeks
次要结局
- The proportion of patients requiring platelet rescue therapy(From enrollment up to Day 21)
- The proportion of patients whose next chemotherapy cycle is delayed (≥4 days)(From enrollment up to Day 25)
- The proportion of patients with platelet count >75×10⁹/L on day 21 (D21)(From enrollment up to Day 21)
- The proportion with platelet count >100×10⁹/L on day 21 (D21)(From enrollment up to Day 21)
- The proportion of patients with platelet count <50×10⁹/L(From enrollment up to Day 21)
研究者
研究点 (1)
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