NCT07019181尚未招募2 期
Tislelizumab Combined With Chemotherapy for the Perioperative Treatment of Esophageal Squamous Carcinoma： Single-arm Clinical Phase II Study
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 26
- 主要终点
- Pathological complete response rate
研究概览
简要总结
Evaluating the rate of pathologic complete remission in patients with squamous esophageal cancer treated perioperatively with tislelizumab in combination with chemotherapy
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects were enrolled in the study and signed an informed consent form.
- •Male or female patients between the ages of 18 and
- •Patients with esophageal squamous carcinoma diagnosed by histopathology.
- •According to the TNM staging system of esophageal cancer in the 8th edition of the AJCC,the disease is in the stage of cT3-4aN0M0 or cT1b-4aN+M0 (confirmed by thoracic and abdominal enhancement CT/MRI), and the lesion is located in the thoracic segment.
- •ECOG score: 0-
- •Normal functioning of major organs, i.e. meeting the following criteria.
- •Blood count (no blood transfusions, granulocyte colony-stimulating factor [G-CSF], or other medications corrected within 14 days prior to treatment); and Absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin (HB) ≥9.0 g/dL; and Platelet count (PLT) ≥ 100 x 109/L;
- •blood biochemistry Creatinine clearance ≥60 mL/min. Total bilirubin (TBIL) ≤ 1.5 x ULN. Albuminous aminotransferase (AST) or albuminous aminotransferase (ALT) levels ≤ 2.5 x ULN;
- •Expected survival > 6 months.
- •Female subjects of childbearing potential and male subjects with partners of childbearing potential are required to use a medically approved contraceptive method during study treatment and for at least 6 months after the last treatment.
排除标准
- •The presence of clinically uncontrolled chest that required repeated drainage or medical intervention (within 2 weeks prior to randomization) Hydrocele, pericardial hydrocele or ascites;
- •Known intolerance or resistance to chemotherapy specified in the trial protocol;
- •Have received any other ESCC anti-tumor therapy (e.g., targeting PD-1, PD-L1, PD-L2) Or other tumor immunotherapy, radiotherapy, targeted therapy, ablation, or other systemic or local anti-tumor therapy);
- •Patients who have an active autoimmune disease or have a history of an autoimmune disease but may relapse may have a known abnormality History of body organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •A history of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic disease, including pulmonary fibrosis, Acute lung disease;
- •There were severe chronic or active patients requiring systemic antimicrobial therapy, antifungal therapy or antiviral therapy before enrollment Infection (including tuberculosis infection, etc.);
- •Have a known history of HIV infection;
- •The presence of any serious or uncontrolled systemic disease, including but not limited to:
- •Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure; Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, cerebrovascular accident, or transient ischemic attack, during the 6 months prior to the first dose of the study; Uncontrolled hypertension (i.e., ≥ CTC-AE level 2 hypertension after medication); active pulmonary tuberculosis; those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders;
- •Had other malignancies in the past 5 years (cured skin basal cell carcinoma, breast carcinoma in situ and Except primary cervical cancer);
- •Had received live vaccine within 28 days prior to enrollment;
- •Have participated in other therapeutic clinical trials within 4 weeks;
- •And those deemed unsuitable for inclusion by the researchers.
研究组 & 干预措施
Tislelizumab combined with chemotherapy
Experimental
干预措施: Tislelizumab (Drug)
Tislelizumab combined with chemotherapy
Experimental
干预措施: albumin-bound paclitaxel (Drug)
Tislelizumab combined with chemotherapy
Experimental
干预措施: Nedaplatin (Drug)
结局指标
主要结局
Pathological complete response rate
时间窗: 4 weeks after surgery
Pathological complete responseTotal tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
次要结局
- Major pathological response rate(4 weeks after surgery)
- Objective Response Rate(At the end of Cycle 2(each cycle is 28 days))
研究者
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