NCT04520035Unknown2 期
A Prospective, Single Arm, Single Center, Phase II Clinical Trial of Neoadjuvant Chemotherapy With Camrelizumab in Locally Advanced Esophageal Squamous Cell
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pathological complete response rate (pCR)
研究概览
简要总结
A prospective, single arm, single center, phase II clinical trial of neoadjuvant chemotherapy with camrelizumab in locally advanced esophageal squamous cell,to evaluate the progression free survival
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
- •The age ranged from 18 to 75 years
- •Middle or lower thoracic esophageal carcinoma
- •Gastroscopy showed squamous cell carcinoma
- •The clinical stage was c-txn1-3m0
- •ECOG score was 0-1
- •Can eat semifluid
- •Weight loss less than 20% in 6 months
- •Sign the consent form before treatment
- •One week before enrollment, the organ function level reached the following standards:
- •Bone marrow function: hemoglobin ≥ 100g / L, WBC ≥ 4.0 * 10 ^ 9 / L, neutrophil count ≥ 1.8 * 10 ^ 9 / L, platelet count ≥ 100 * 10 ^ 9 / L;
- •Liver: serum total bilirubin level ≤ 1.5 times normal upper limit value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 times normal upper limit value;
- •Kidney: serum creatinine level is lower than 1.5 times of normal upper limit value or creatinine clearance rate ≥ 60ml / min, urea nitrogen ≤ 200mg / L;
- •Blood glucose: within the normal range and / or patients with diabetes are under treatment, but the blood glucose is controlled in a stable state;
- •Lung function: baseline FEV1 should be at least 2L; if the baseline FEV1 < 2L, it should be evaluated by surgical experts, and FEV1 > 800ml after surgery should be predicted;
- •Cardiac function: no myocardial infarction within 1 year; no unstable angina pectoris; no symptomatic severe arrhythmia; no cardiac insufficiency.
排除标准
- •The pathological findings were complex squamous cell carcinoma, including squamous adenocarcinoma, squamous cell carcinoma, carcinosarcoma, sarcomatoid carcinoma, etc
- •He had a history of subtotal gastrectomy
- •Patients with secondary primary cancer at the same time
- •The patients with distant metastasis indicated by imaging before treatment
- •Except for skin basal cell carcinoma, skin squamous cell carcinoma and / or cervical carcinoma in situ after effective treatment
- •Patients who have received chemoradiotherapy in the past
- •There were signs of esophageal perforation
- •Pregnant women of childbearing age
- •The patient has any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, etc.)
- •There are patients with the following active infectious diseases, including active pulmonary tuberculosis, active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analysis method), and known human immunodeficiency virus (HIV) infection
- •Those who are known to have bleeding diseases or other uncontrollable diseases and are unable to receive surgical treatment
- •Findings of physical examination or clinical trials that the researchers believe may interfere with the results or increase the risk of treatment complications for patients
- •Function of each organ of the patient:Previous interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy, or any active interstitial lung disease with clinical evidence, CT scan at baseline found the presence of idiopathic pulmonary fibrosis; uncontrolled massive pleural effusion or pericardial effusion;
- •Unstable systemic concomitant diseases (active infection, moderate to severe chronic obstructive pulmonary disease, poorly controlled hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction within 6 months, severe mental disorders requiring drug control, liver, kidney or other metabolic diseases, neuropsychiatric diseases such as Alzheimer's disease);
- •Poor gastrointestinal function, absorption syndrome and active peptic ulcer;
- •Have received any of the following treatments:
- •Have received anti-PD-1 or anti-PD-L1 antibody treatment in the past; 2) Received any research drug within 4 weeks before the first use of the study drug; 3) At the same time, they were enrolled in another clinical study, unless it was an observational (non intervention) clinical study or an intervention clinical study follow-up; 4) Have received any anti-tumor treatment related to esophageal cancer, including but not limited to radiotherapy, chemotherapy, surgery, ESD, EMR, immunotherapy, targeted therapy, and traditional Chinese medicine treatment; 5) Subjects who needed systemic treatment with corticosteroids (10 mg prednisone equivalent dose per day) or other immunosuppressants within 2 weeks before the first use of the study drug were excluded from the use of corticosteroids for local esophageal inflammation and prevention of allergy, nausea and vomiting. Other special circumstances, need to communicate with the sponsor. In the absence of active autoimmune disease, inhaled or topical corticosteroids and corticosteroids with dose > 10 mg / day prednisone were allowed to be used instead; 6) Those who have received anti-tumor vaccine or received live vaccine within 4 weeks before the first administration of the study drug; 7) Major surgery or severe trauma occurred within 4 weeks before the first use of the study drug;
- •History of congenital or acquired immunodeficiency disease or organ transplantation;
- •He had a history of allergy to monoclonal antibodies, paclitaxel, cisplatin and other platinum drugs;
研究组 & 干预措施
neoadjuvant chemotherapy with camrelizumab
Experimental
paclitaxel and cisplatin
Carilizumab 200 mg, every 3 weeks, 2 cycles.
Paclitaxel 175 mg / m2, D1, every 3 weeks, 2 cycles
Cisplatin 75mg / m2 D1, conventional hydration for 3 days, every 3 weeks, 2 cycles
干预措施: camrelizumab (Drug)
neoadjuvant chemotherapy with camrelizumab
Experimental
paclitaxel and cisplatin
Carilizumab 200 mg, every 3 weeks, 2 cycles.
Paclitaxel 175 mg / m2, D1, every 3 weeks, 2 cycles
Cisplatin 75mg / m2 D1, conventional hydration for 3 days, every 3 weeks, 2 cycles
干预措施: Paclitaxel (Drug)
neoadjuvant chemotherapy with camrelizumab
Experimental
paclitaxel and cisplatin
Carilizumab 200 mg, every 3 weeks, 2 cycles.
Paclitaxel 175 mg / m2, D1, every 3 weeks, 2 cycles
Cisplatin 75mg / m2 D1, conventional hydration for 3 days, every 3 weeks, 2 cycles
干预措施: Neoadjuvant Chemotherapy (Drug)
结局指标
主要结局
Pathological complete response rate (pCR)
时间窗: from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days)
Pathological complete response rate
次要结局
未报告次要终点
研究者
Jialei Wang
Principal Investigator
Fudan University
研究点 (1)
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