NCT06303583Enrolling By Invitation1 期
Neoadjuvant Chemoradiotherapy Followed by Sequential Immunotherapy for Thoracic Esophageal Squamous Cell Carcinoma
Qiu Guoqin1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete pathological response rate
研究概览
简要总结
The purpose of study is to investigate the safety and efficacy of sequential immunotherapy with neoadjuvant chemoradiotherapy for esophageal cancer
详细描述
This is a single-arm, phase Ib study. Eligibility criteria include histologically confirmed ESCC and clinical T3-4aN0M0 or T2-4aN+M0 (AJCC/UICC 8). Patients received neoadjuvant radiotherapy (41.4Gy in 23 fractions) with concurrent chemotherapy (paclitaxel, 50 mg/m2, carboplatin area under the curve of 2mg/mL/min, QW*5). Then followed by two cycles of tislelizumab (200mg, Q3W). The primary endpoint was the pathological complete response (pCR) rate and safety.
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
- •Histology confirmed thoracic esophageal squamous cell carcinoma.
- •ECOG ps 0 to
- •Resectable or potentially resectable T2-4aN0 or T1-4aN+ patients (AJCC/UICC Clinical Staging of Esophageal squamous cell Carcinoma, 8th edition (cTMN)).
- •Length of esophageal lesions <8cm.
- •There were no surgical contraindications.
- •Neutrophil count ≥1.5*109/L, platelet count ≥10.0*109/L, hemochrome ≥9g/dL; Serum creatinine ≤1.5 times the upper limit of normal value; Bilirubin ≤1.5 times the upper limit of normal value, AST, ALT, AKP≤2.5 times the upper limit of normal value.
- •BMI acuity 18.5 kg/m
- •Informed notification and signed informed consent.
排除标准
- •Cervical esophageal cancer (upper part of the lesion in the cervical esophagus). Multifocal esophageal carcinoma, lesion length >8cm.
- •Trachea and aorta were invaded (Annex 5).
- •Hoarseness caused by the tumor.
- •Esophageal fistula.
- •Lymph node metastasis in the neck and periceliac artery (AJCC/UICC 8th edition esophageal/esophagogastric junction region lymph node division 1 and 20).
- •A history of active autoimmune disorders or syndromes requiring treatment with systemic steroids or immunosuppressants (except for vitiligo or cured childhood asthma/allergies who do not require any intervention in adulthood; Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone).
- •She is on hormonal or immunosuppressive therapy.
- •He's had an organ transplant.
- •HIV infection, hepatitis C (hepatitis C antibody positive with HCV-RNA above the detection limit of the assay), chronic active hepatitis B (HBV DNA≥2×103IU/ml or >1×104copies/mL).
- •Active tuberculosis, interstitial pneumonia, active infection, poorly controlled diabetes, symptomatic arrhythmia, symptomatic new dysfunction, myocardial infarction, active peptic ulcer, chronic active enteritis within 6 months; Affected during pregnancy or lactation.
- •Major surgery in the last three months.
- •Severe diabetes mellitus with poor drug control, symptomatic arrhythmia, symptomatic cardiac insufficiency, myocardial infarction within 6 months, chronic active enteritis, chronic nephritis. QTc acuity 470 ms.
- •He had a history of malignancy. Previously received chemotherapy, radiotherapy, targeted therapy, immunotherapy and other antitumor therapies.
- •Patients with allergic or contraindicated taxa.
- •Live vaccine is administered within 30 days before the first dose of immunotherapy.
- •Refusal or inability to sign up for ICF study.
- •The investigator decided that the patient was not suitable to participate.
研究组 & 干预措施
IO
Experimental
chemoradiotherapy sequential tislelizumab
干预措施: paclitaxel (Drug)
IO
Experimental
chemoradiotherapy sequential tislelizumab
干预措施: carboplatin (Drug)
IO
Experimental
chemoradiotherapy sequential tislelizumab
干预措施: tislelizumab (Drug)
IO
Experimental
chemoradiotherapy sequential tislelizumab
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Complete pathological response rate
时间窗: 1 year
次要结局
- 2-year overall survival rate(2 years)
- 2-year Disease-free survival rate(2 years)
- Safety will be analyzed through the incidence of adverse events, serious adverse events(Up to 28 days from last dose)
- R0 resection rate(1 year)
研究者
Qiu Guoqin
Chief Physician
Zhejiang Cancer Hospital
研究点 (1)
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