Simultaneous Integrated Boost Radiotherapy and Concurrent Nimotuzumab or Chemotherapy for Esophageal Carcinoma

• Status: Unknown status
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This prospective, non-randomized phase II study aims to compare radiotherapy and concurrent nimotuzumab with concurrent chemoradiotherapy to obtain a non-inferior pCR rate and pathological lymph node metastases rate in premise of lower toxicities in locally advanced esophageal cancer.

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

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborators: Affiliated Hospital of Hebei University; Beijing Army General Hospital; Beijing Hospital; Fujian Cancer Hospital; Hebei Medical University Fourth Hospital; Henan Cancer Hospital; Peking University First Hospital; The Affiliated Hospital of Inner Mongolia Medical University; The First Affiliated Hospital with Nanjing Medical University; Tianjin Medical University Cancer Institute and Hospital
• Treatments: Albumin-Bound Paclitaxel; Nedaplatin; Nimotuzumab; Paclitaxel; Polystyrene sulfonic acid

Criteria

Inclusion Criteria:

• Diagnosis of clinical stage T1-4aN0-1M1a untreated squamous esophageal carcinoma

• KPS≥70

• Adequate organ function

• No known history of drug allergy

Exclusion Criteria:

• Known drug allergy

• Insufficient hepatorenal function

• Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.