Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Clinical Trial

Study Design Primary Purpose: To evaluate the response rate, progression-free survival, overall survival and complications.

Study Phase: Phase II Intervention Model: Targeted therapy combined with radiotherapy Number of Arms: One Masking: No Allocation: 30 patients for one single group Enrollment: 30 patients

Eligibility Criteria Inclusion Criteria: 1. ≥ 70 year-old, 2. Thoracic segment esophageal cancer with stage II to IV (supraclavicular lymph node metastasis only), 3. No previous surgery, radiotherapy or chemotherapy of cancer was allowed, 4. Estimated survival time ≥ 3 months, 5. KPS > 60, 6. No serious diseases of important organs, 7. Signed consent forms voluntarily.

Exclusion criteria

1. Psychopath, 2. History of other malignant disease which has not been cured, 3. Joining other clinical trial prior this study.

Inclusion criteria

• patients aged 70 years or older;
• treatment naive patients with histologically proven thoracic-segment EC that was inoperable and who could not tolerate CCRT;
• stage II-IV disease (supraclavicular lymph node metastasis only), according to the 6th American Joint Committee on Cancer TNM staging system;
• estimated survival time ≥3 months;
• Karnofsky performance score ≥70;
• adequate bone marrow, as well as hepatic and renal function;
• voluntary written consent provided prior to treatment.

Exclusion criteria

• esophagobronchial or esophagomediastinal fistula;
• patients who had joined other clinical trials prior to this treatment;
• serious heart, liver, and/or kidney insufficiency;
• serious infectious disease;
• relapse disease or distant metastasis;
• recently diagnosed neoplastic diseases;
• previous receipt of surgery, chemotherapy, or radiotherapy for EC.