Unresectable Esophageal Cancer Clinical Trial
Official title:
Efficacy and Safety of Neo-Radiochemotherapy Followed Surgery Compared With Definitive Radiochemotherapy in Patients With Initial Unresectable Esophageal Cancer
Definitive chemoradiotherapy(CRT) has been regarded as a standard of care for patients with unresectable locally advanced esophageal cancer. Patients who are sensitive to CRT can achieve significantly down staging. Whether this part of patients could benefit from further surgical treatment remains unknown. Herein, a single center prospective randomized phase II clinical trial will be carried out to compare efficacy and safety of definitive CRT versus neo-CRT plus radical resection in patients who achieved down staging after neo-CRT for stage T4NxM0 esophageal Cancer.
1. Compare progression-free survival (PFS) and overall survival (OS) of definitive
radiochemotherapy versus(VS) neoadjuvant radiochemotherapy plus radical resection for
esophageal cancer patients who down stage from inoperable to operable after neoadjuvant
treatment;
2. Compare the toxic and side effects of definitive radiochemotherapy versus neoadjuvant
radiochemotherapy plus radical resection for esophageal cancer patients who achieved
clinical complete remission after neoadjuvant treatment;
3. Assess impact of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus
radical resection on quality of life of patients.
Concurrent Radiochemotherapy: Radiotherapy, Intensity Modulation Radiation Therapy(IMRT),
40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2), 1st/8th/15th/22nd day
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04005170 -
Combination of Toripalimab and Chemoradiotherapy in Esophageal Cancer
|
Phase 2 | |
| Recruiting |
NCT06251973 -
A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer
|
Phase 2 |