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dCRT vs. Surgery in Resectable ESCC Patients Achieving cCR/PR After Induction Chemoimmunotherapy

Study acronym: SORT
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria shortened, about 28 words
    • Study title expanded, about 1 word
  2. Eligibility criteria revisedv7
  3. Start date: Aug 1, 2025 to Nov 3, 2025v6
  4. Interventions: Chemotherapy (Drug), Radiotherapy (Radiation), Surgery (Procedure) to Chemotherapy (Drug), Immunotherapy (Drug), Radiotherapy (Radiation), Surgery (Procedure)
    • Eligibility criteria expanded, about 37 words
    • Collaborators expanded, about 12 words
    v5
  5. Re-verified, no change to tracked fieldsv4
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  1. Eligibility criteria expanded, about 5 wordsv3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07162506
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Collaborators: Shanxi Province Cancer Hospital, Sichuan Province Cancer Hospital, Henan Province Cancer Hospital
Conditions
(from sponsor)		 Esophageal Cancer
Related terms Esophageal Neoplasms
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov