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

• Status: Completed
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

Summary

For patients who are unable to receive surgery or having local advanced esophageal cancer stages, concurrent chemoradiotherapy is recommended. But radiotherapy is the main strategy for older patients because of their chemoradiotherapy intolerance. The whole world focused on targeted therapy which has strong specialties and mild toxicities. So combined targeted therapy and radiotherapy may be a novel strategy for older patients with esophageal cancer. Nimotuzumab is a EGFR monoclonal antibody. This clinical trial is to study the effect and safety of Nimotuzumab in combined with radiotherapy for older patients with esophageal cancer. All patients receive intensity modulated radiotherapy with conventional fraction. Nimotuzumab with 200mg is given weekly for all patients during radiotherapy.

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

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Nimotuzumab

Criteria

Inclusion Criteria:

1. patients aged 70 years or older;

2. treatment naive patients with histologically proven thoracic-segment EC that was inoperable and who could not tolerate CCRT;

3. stage II-IV disease (supraclavicular lymph node metastasis only), according to the 6th American Joint Committee on Cancer TNM staging system;

4. estimated survival time ≥3 months;

5. Karnofsky performance score ≥70;

6. adequate bone marrow, as well as hepatic and renal function;

7. voluntary written consent provided prior to treatment.

Exclusion Criteria:

1. esophagobronchial or esophagomediastinal fistula;

2. patients who had joined other clinical trials prior to this treatment;

3. serious heart, liver, and/or kidney insufficiency;

4. serious infectious disease;

5. relapse disease or distant metastasis;

6. recently diagnosed neoplastic diseases;

7. previous receipt of surgery, chemotherapy, or radiotherapy for EC.