NCT05515315招募中2 期
Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of locally unresectable esophageal squamous cell carcinoma (ESCC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed localized ESCC that is suitable for cCRT, including: stage II-IVA (AJCC version 8) inoperable ESCC (medically unfit for surgery or refusing surgical intervention);;
- •Aged 18-70, both sexes;
- •ECOG score 0-1
- •The presence of measurable and/or nonmeasurable lesions that met the definition of RECIST1.1;
- •Adequate organ and bone marrow function, meeting the following definitions:
- •Blood routine (no blood transfusion, no granulocyte colony-stimulating factor [G-CSF], and no other drugs were used within 14 days before treatment);Absolute neutrophil count (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count (PLT) ≥100×109/L;
- •Blood biochemistry Creatinine clearance rate ≥60 mL/min;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;
- •Expected survival time > 6 months;
- •Fertile female subjects and male subjects with partners of reproductive age are required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last treatment;
- •Patients who volunteered to participate in this study and signed the informed consent form.
排除标准
- •A history of fistula caused by primary tumor invasion;
- •Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites that required repeated drainage or medical intervention (within 2 weeks before randomization);
- •Known intolerance or resistance to chemotherapy specified in the trial protocol;
- •have received any other ESCC antitumor therapy (e.g., therapy targeting PD-1, PD-L1, PD-L2 or other tumor immunotherapy, radiotherapy, targeted therapy, ablation or other systemic or local antitumor therapy);
- •Patients with active autoimmune disease or a history of autoimmune disease that may relapse, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •History of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis and acute lung disease;
- •Severe chronic or active infection (including tuberculosis infection) requiring systemic antimicrobial therapy, antifungal therapy or antiviral therapy before enrollment;
- •Known history of HIV infection;
- •Other malignancies (except cured basal cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix) in the past 5 years;
- •Received live vaccine within 28 days before enrollment;
- •while participating in another therapeutic clinical trial.
研究组 & 干预措施
Tislelizumab combined with chemothapy
Experimental
干预措施: Tislelizumab (Drug)
Tislelizumab combined with chemothapy
Experimental
干预措施: Albumin paclitaxel (Drug)
Tislelizumab combined with chemothapy
Experimental
干预措施: Nedaplatin (Drug)
Tislelizumab combined with chemothapy
Experimental
干预措施: radiotherapy (Radiation)
结局指标
主要结局
progression free survival
时间窗: up to 24 months
Time from enrollment to the onset of disease progression or death
次要结局
- Objective Response Rate (ORR)(every 6 weeks （up to 24 months）)
- Overall survival (OS)(every 3 months (up to 24 months))
研究者
研究点 (1)
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