Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients

• Status: Recruiting
• Trial end date: 2027-10-31
• Target enrollment: 0
• Participant gender: All

Summary

Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received radical surgery. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation. The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborators: Anyang Cancer Hospital; Anyang Tumor Hospital; Beijing Cancer Hospital; Fujian Cancer Hospital; Hebei Medical University Fourth Hospital; The First Affiliated Hospital with Nanjing Medical University; Tianjin Medical University Cancer Institute and Hospital
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Locoregional recurrence after radical surgery;

• Positive resection margin (R1/R2) after surgery;

• Out-of-field recurrence after adjuvant chemoradiation or radiotherapy;

• Recurrence after adjuvant chemotherapy;

• No prior therapy after recurrence;

• Age 16-70 years;

• KPS>70;

• No history of drug allergy;

• Sufficient liver and kidney functions;

• White blood cell count > 4.0*10^9/L.

Exclusion Criteria:

• Age>70 or <16 years;

• Pregnancy or lactation;

• History of drug allergy;

• Declining informed consent;

• Insufficient liver or kidney functions, or abnormal CBC test;

• Severe cardiovascular diseases, infections, active ulcerations, diabetes mellitus with unstable blood sugar, mental disorders.