Nimotuzumab Concurrent With Chemoradiotherapy for Elderly or Malnourished Patients With Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Study

What this Trial Is About

Researchers are studying elderly or malnourished patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) to evaluate a new treatment approach for those with unresectable ESCC. This phase II trial focuses on assessing the success of removing the tumor completely (R0 resection rate), the rate of complete pathological response, and monitoring treatment-related side effects. Nimotuzumab, a humanized antibody targeting EGFR, has shown promise in previous studies for esophageal cancer, and this study explores its use combined with chemotherapy and radiotherapy. The treatment combines weekly doses of nimotuzumab at 800 mg along with the chemotherapy drug S-1, taken orally twice daily on days of radiotherapy. Radiotherapy is delivered in doses ranging from 40 to 50.4 Gy over 20 to 28 sessions. This combined chemoradiotherapy is followed by surgery when possible. The study is designed as a single-arm trial to observe how well this regimen works and its safety profile in the target patient group. Participants will be monitored through various assessments including blood tests to check organ and marrow function, evaluation of tumor response at four months after starting treatment, and follow-up for survival and complications up to one year post-treatment. Researchers will also observe event-free survival one month after chemoradiotherapy and postoperative complications one month after surgery. The total study duration includes these follow-up periods to understand the treatment impact and patient outcomes.

Nimotuzumab Concurrent With Chemoradiotherapy for Esophageal Cancer Patients