Changes in Tumor Tissue and Serum Biomarkers Before and After Cetuximab Combined With Preoperative Radiotherapy in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan Cancer Hospital and Research Institute
• Collaborators: Affiliated Cancer Hospital & Institute of Guangzhou Medical University; Affiliated Tumor Hospital of Guangzhou Medical University; Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; Southwest Hospital, China; Xinqiao Hospital of Chongqing
• Treatments: Cetuximab

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:

1. Patient who have distant metastasis

2. The primary tumor or lymph node already received surgical treatment (except for biopsy);

3. Patient who received radiotherapy for primary tumor or lymph node;

4. Patient who received the the epidermal growth factor targeted therapy;

5. Patient who received chemotherapy or immunotherapy;

6. Patient who suffered from other malignant tumor;

7. Epidermal growth factor receptor（EGFR）mutation（-）;

8. Patient who have taken other drug test within 1 month;

9. Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period;

10. Subject with a severe allergic history or idiosyncratic;

11. Subject with severe pulmonary and cardiopathic disease history; Refuse or incapable to sign the informed consent form of participating this trial;

12. Drug abuse or alcohol addicted;

13. Subject with a Personality or psychiatric diseases, people with no legal; capacity or people with limited capacity for civil conduct;