NCT06512428招募中2 期
An Open-label, Multicenter Phase II Clinical Trial to Explore the Safety and Efficacy of Simmitinib Plus Irinotecan Liposome in Patients With Advanced Esophageal Squamous Cell Carcinoma
Shanghai Runshi Pharmaceutical Technology Co., Ltd1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年3月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Dose Escalation Phase: DLT
研究概览
简要总结
To evaluate the safety and efficacy of simmitinib plus irinotecan liposome in the treatment of advanced esophageal squamous cell carcinoma, and to evaluate the PK of the drug and the correlation between biomarkers and clinical efficacy of simmitinib plus irinotecan liposome.
详细描述
The experiment was divided into two stages. The first stage is dose escalation stage. Rapid titration and "3+3" dose escalation design were used to observe DLT of simmitinib plus irinotecan liposome, and MTD was determined. The second stage is a randomized controlled study. After RP2D was determined in the first stage, participants were randomly assigned to 3 groups in a 1:1:1 ratio, including simmitinib plus irinotecan liposome, irinotecan liposome, and irinotecan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have fully understood and voluntarily sign the ICF for this study;
- •Age of 18-70 years (inclusive), male or female;
- •Esophageal squamous cell carcinoma confirmed histologically or cytologically
- •Second-line patients with disease progression after only first-line standard therapy（Standard treatment: chemotherapy with platinum plus fluorouracil or taxane combined with immunosuppressive regimen .Progression during adjuvant/neoadjuvant therapy or within 6 months of the last dose is considered a first-line standard treatment failure）
- •At least one measurable lesion according to RECIST 1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1;
- •Expected survival is more than 3 months
- •Adequate organ function, defined as:
- •Absolute Neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count (PLT) ≥ 75× 10^9/L; Hemoglobin (Hb) ≥ 90 g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (≤ 5.0 × ULN for patients with liver metastases); Serum total bilirubin (TBIL) ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN and Creatinine clearance (CCr)≥60mL/min; Prothrombin time (PT)、activated partial thromboplastin time (APTT)、international normalized ratio(INR)≤1.5 × ULN;
- •Male and female patients of childbearing age must agree to take effective contraceptive measures during treatment and within 6 months after the last dose of treatment.
- •Exclusion Criteria
- •Patients who have previously received any anti-tumor therapy within 4 weeks prior to the first dose;
- •Patients who have previously received any live attenuated vaccine within 4 weeks before the first use of the study treatment or are expected to received any live attenuated vaccine during the study;
- •Prior systemic treatment with anti-VEGF drugs, irinotecan, or any other topoisomerase I inhibitor
- •LVEF <50%；
- •BMI≤18.5 kg/m^2
- •Symptomatic central nervous system (CNS) metastases or meningeal metastases;
- •Patients with other types of malignant tumors within 5 years prior to the screening, except for radically resected, non-recurrent skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ, or other carcinoma in situ;
- •Patients with bleeding tendency; active bleeding or a history of heavy bleeding within the past 6 months;
- •Urine protein ≥ ++ and 24 h urine protein > 1.0g at screening period;
- •Presence of any severe and/or uncontrolled disease before starting treatment;
- •Severe lung disease within 6 months before first dosing ；
- •Any active infection requiring antibiotics or hormones systemic treatment by intravenous infusion within 14 days prior to the first dose;
- •Inability to swallow drugs orally, or presence of clinically significant gastrointestinal disorders
排除标准
- 未提供
研究组 & 干预措施
simmitinib plus irinotecan liposome
Experimental
干预措施: simmitinib plus irinotecan liposome (Drug)
irinotecan liposome
Experimental
干预措施: irinotecan liposome (Drug)
irinotecan
Experimental
干预措施: irinotecan (Drug)
结局指标
主要结局
Dose Escalation Phase: DLT
时间窗: From Cycle 1 Day 1 to Cycle 1 Day 28 (each cycle is 28 days)
Dose Limited Toxicity
Dose Escalation Phase: AE
时间窗: From first dose to 30 days post the last dose
Incidence rate of Adverse Event
Randomized controlled study phase: ORR
时间窗: 2 years
Objective Response Rate (ORR) evaluated by investigators based on RECIST 1.1
次要结局
- DOR(2 years)
- DCR(2 years)
- PFS(2 years)
- OS(2 years)
- Peak Plasma Concentration (Cmax)(2 years)
- Area under plasma concentration (AUC)(2 years)
- Time of peak plasma concentration (Tmax)(2 years)
研究者
研究点 (1)
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