NCT06356688招募中2 期
A Clinical Study on the Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Single-Arm, Single-Center, Prospective Clinical Trial (POINTS Trial)
Sun Jing1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月20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
- 30
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR) rates
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with a PD-1/CTLA-4 bispecific antibody (Cadonilimab) in combination with platinum-containing chemotherapy (Paclitaxel Polymeric Micelles for Injection combined with Cisplatin). Includes pathologic complete remission rates (pCR rates) after 2-4 cycles of Cadonilimab combination chemotherapy. The objective remission rate (ORR), major pathologic remission rate (MPR), R0 resection rate and 2-year overall survival (OS) and progression-free survival (OS) rates, and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with Cadonilimab combined 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
- •Age ≥18 years, ≤75 years, gender is not limited;
- •Squamous esophageal cancer of thoracic segment confirmed by pathology;
- •Locally advanced patients with no distant metastasis by imaging, resectable or potentially resectable after discussion among oncology, esophageal surgery, and imaging, and clinical stage cT2-4aN+ or cT3-4aN0, M0, stage II, III, or IVA (AJCC 8th edition cTNM staging);
- •ECOG PS score of 0-1;
- •No previous antitumor treatment such as radiotherapy, chemotherapy and immunotherapy;
- •Expected survival > 6 months;
- •Adequate baseline organ function: (i) WBC ≥3×10^9/L, ANC ≥1.5×10^9/L, PLT ≥100×10^9/L, Hb ≥9g/dL; (ii) Liver function: TBIL ≤2ULN, AST ≤2.5ULN, ALT ≤2.5ULN; (iii) Renal function: cCr>40 ml/min, Cr≤1.5 ULN; (iv) Cardiac function: no cardiac disease or coronary artery disease. Cardiac function: no heart disease or coronary heart disease, patients with cardiac function grade 1-2;
- •Hypertensive patients applying antihypertensive drugs to control blood pressure within the normal range;
- •Diabetic patients with fasting blood glucose controlled at ≤8mmol/L by hypoglycemic drug treatment;
- •No other serious diseases (such as autoimmune diseases, immunodeficiency, organ transplantation, or other diseases that require continuous hormone therapy) that conflict with this protocol;
- •No history of other malignant tumors;
- •The patient agrees to participate in this clinical study and signs the Informed Consent Form.
排除标准
- •Patients who have previously received anti-tumor therapy (including chemotherapy, radiotherapy, surgery or immunotherapy, etc.);
- •Combination of other incurable malignant tumors (except cured non-malignant skin tumors, cervical cancer in situ, and prostate cancer);
- •Patient has or anticipates a significant risk of esophageal perforation, fistula, and hemorrhage;
- •Active autoimmune or immunodeficiency disease, use of immunosuppressants prior to enrollment, and use of immunosuppressant dosage ≥10 mg/day of oral prednisone for more than 2 weeks;
- •Clinically significant cardiovascular disease including, but not limited to, severe acute myocardial infarction, unstable or severe angina pectoris, coronary artery bypass grafting surgery, congestive heart failure, ventricular arrhythmia requiring medical intervention, left ventricular ejection fraction <50%, or other anticipated inability to tolerate chemoradiotherapy in the 6 months prior to enrollment;
- •Severe allergies;
- •Pregnant or lactating women;
- •Severe mental disorders;
- •Presence of CTC grade ≥3 peripheral nerve disease;
- •Abnormal coagulation function (PT > 16s, APTT > 53s, TT > 21s, Fib < 1.5g/L), bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
- •Presence of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, severe impairment of lung function, or active tuberculosis within 1 year;
- •Presence of active hepatitis B or C;
- •Any other condition that the investigator evaluates to be ineligible for enrollment.
研究组 & 干预措施
Paclitaxel Polymeric Micelles for Injection and Cisplatin Combined with Cadonilimab
Experimental
干预措施: Paclitaxel Polymeric Micelles for Injection and Cisplatin combined with Cadonilimab (Drug)
结局指标
主要结局
Pathological complete response (pCR) rates
时间窗: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
evaluate pathological complete response rate of primary tumor and locally metastatic lymph nodes after 2-4 cycles of neoadjuvant therapy.
次要结局
- R0 Removal Rate(From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.)
- 2-year overall survival rate(2 years)
- 2-year disease free survival rate(2 years)
- Objective Rate of Effectiveness (ORR)(From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.)
- major pathological response (MPR)(From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.)
研究者
Sun Jing
chief physician、professor
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
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