Changes in Tumor Tissue and Serum Biomarkers Before and After Cetuximab Combined With Preoperative Radiotherapy in Locally Advanced Middle or Lower Thoracic Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Expression of Survivin protein in Esophageal Squamous Cell Carcinoma before and after Radiotherapy
研究概览
简要总结
This study aim to investigate Changes in tumor tissue and serum biomarkers before and after cetuximab combined with preoperative radiotherapy in locally advanced thoracic middle-lower segment esophageal squamous cell carcinoma.We want to find one or more effective biomarkers to predict and evaluate the patients who will be benefit from cetuximab combined with preoperative radiotherapy.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)18 to 65 years old,male or female (2)Pathologically or cytologically proven thoracic middle-lower esophageal squamous cell carcinoma; (3)clinical stage II or stage III; (4)Primary tumors can be measured; (5)Karnofsky score >70; (6)Estimated life expectancy of at least 12 weeks; (7)reproductive age women should ensure that before entering the study period contraception; (8)Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³; (9)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal; (10)Creatinine normal OR creatinine clearance ≥ 60 mL/min; (11)Patients have good compliance to treatment and follow-up of acceptance; (12)Forced expiratory volume in one second（FEV1） ≥ 1.5 litre or ≥ 75% of the reference value; (13)Considered operable (i.e. appropriate organ functions and ability to undergo general anesthesia); (14)No severe or uncontrolled cardiovascular disease; (15)No active uncontrolled infection;
排除标准
- •Patient who have distant metastasis
- •The primary tumor or lymph node already received surgical treatment (except for biopsy);
- •Patient who received radiotherapy for primary tumor or lymph node;
- •Patient who received the the epidermal growth factor targeted therapy;
- •Patient who received chemotherapy or immunotherapy;
- •Patient who suffered from other malignant tumor;
- •Epidermal growth factor receptor（EGFR）mutation（-）;
- •Patient who have taken other drug test within 1 month;
- •Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period;
- •Subject with a severe allergic history or idiosyncratic;
- •Subject with severe pulmonary and cardiopathic disease history; Refuse or incapable to sign the informed consent form of participating this trial;
- •Drug abuse or alcohol addicted;
- •Subject with a Personality or psychiatric diseases, people with no legal; capacity or people with limited capacity for civil conduct;
研究组 & 干预措施
Arm A
All patients in the arm receive cetuximab combined with preoperative radiotherapy at first. 4-6 weeks after the rdiaotherapy，patients receive right thoracotomy with three incisions radical surgery.
干预措施: preoperative radiotherapy (Radiation)
Arm A
All patients in the arm receive cetuximab combined with preoperative radiotherapy at first. 4-6 weeks after the rdiaotherapy，patients receive right thoracotomy with three incisions radical surgery.
干预措施: cetuximab (Drug)
结局指标
主要结局
Expression of Survivin protein in Esophageal Squamous Cell Carcinoma before and after Radiotherapy
时间窗: before radiotherapy and 1 months after the radiotherapy
Survivin, an inhibitor of apoptosis protein, is highly expressed in most cancers and associated with radiotherapy resistance, increased tumor recurrence, and shorter patient survival.
Expression of p53 in Esophageal Squamous Cell Carcinoma before and after Radiotherapy
时间窗: before radiotherapy and 1 months after the radiotherapy
p53 (also known as protein 53 or tumor protein 53), is a tumor suppressor protein that in humans is encoded by the TP53 gene.p53 is important in multicellular organisms and involved in preventing cancer.
changes of serum vascular endothelial growth factor（VEGF）level before and after radiotherapy
时间窗: before radiotherapy and 1 months after the radiotherapy
Vascular endothelial growth factor (VEGF) is a signal protein produced by cells that stimulates vasculogenesis and angiogenesis.
次要结局
- Quality of life (QOL)(up to 3 years)
- Overall survival(up to 3 years)
- local control rate（LCR）(up to 3 years)
- grade 3-5 adverse events(up to 3 years)
- PFS（progression-free survival）(up to 3 years)
- Pathological remission(1 months after the end of surgery)
研究者
LI TAO
Section Head
Sichuan Cancer Hospital and Research Institute