Phase 2Recruiting
dCRT vs. Surgery in Resectable ESCC Patients Achieving cCR/PR After Induction Chemoimmunotherapy (SORT)
Surgery or Definitive Chemoradiotherapy in Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma Achieving Clinical Response After Neoadjuvant Chemoimmunotherapy: A Prospective, Preference-Based, Comparative Two-Cohort Phase II Trial (SORT Trial)
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital (Academic or other)
- Enrolment
- 120 planned
- Conditions
- Esophageal Cancer
- Interventions
- Surgery; Radiotherapy; Chemotherapy; Immunotherapy
- Ages
- adults, older adults
- Registry
- NCT07162506
Full record on ClinicalTrials.gov
From the registry
This study is evaluating two treatment approaches for patients with locally advanced, resectable esophageal squamous cell carcinoma (ESCC) who have a good response to 2-3 cycles of induction chemoimmunotherapy. Patients who achieve either a clinical complete response (cCR) or partial response (PR) will be eligible to join the study. After enrollment, patients will choose, together with their doctors, between surgery and definitive chemoradiotherapy (dCRT). Patients in the surgery group will undergo esophagectomy with lymph-node dissection. Patients in the dCRT group will receive radiotherapy together with chemotherapy. After surgery or dCRT, all patients will receive camrelizumab immunotherapy for up to 12 months if they have recovered sufficiently and have no evidence of disease progression. The study will compare the effectiveness and safety of these two treatment approaches and will assess whether dCRT can provide an organ-preserving treatment option for selected patients. The study will enroll approximately 120 patients.
Primary outcomes
- DFS
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered