Changes in Tumor Tissue and Serum Biomarkers Before and After Cetuximab Combined With Preoperative Radiotherapy in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Locally Advanced Thoracic Middle-lower Segment Esophageal Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Locally Advanced Thoracic Middle-lower Segment Esophageal Squamous Cell Carcinoma focused on measuring tumor tissue and serum biomarkers, cetuximab, preoperative radiotherapy, esophageal squamous cell carcinoma
Eligibility Criteria
Inclusion Criteria:
(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;
Exclusion Criteria:
- 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;
Sites / Locations
- Sichuan Cancer Hospital & InstituteRecruiting
Arms of the Study
Arm 1
Experimental
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.