OncoMatch/Clinical Trials/NCT07162506
dCRT vs. Surgery in Resectable ESCC Patients Achieving cCR/PR After Induction Chemoimmunotherapy
Official title: 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)
Is NCT07162506 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Chemotherapy and Immunotherapy for esophageal cancer.
Treatment: Chemotherapy · Immunotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage CT1N1-3M0, CT2-4AN0-3M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: chemoimmunotherapy (PD-1 inhibitor + taxane + platinum agent) — induction
cCR or PR achieved after 2-3 cycles of induction chemoimmunotherapy consisting of a permitted PD-1 inhibitor combined with a taxane and a platinum agent
Cannot have received: surgery for esophageal cancer
Prior surgery for esophageal cancer
Cannot have received: radiotherapy
Radiotherapy
Cannot have received: targeted therapy
targeted therapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5×10^9/L; Platelets ≥ 80×10^9/L; Hemoglobin ≥ 9 g/dL; Serum albumin ≥ 2.8 g/dL; INR and APTT ≤ 1.5× ULN (subjects on stable anticoagulation therapy with INR within expected therapeutic range can be screened)
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min
Liver function
Total bilirubin ≤ 1.5 × ULN, ALT, AST and/or ALP ≤ 2.5 × ULN
The function of major organs meets the following requirements: ... see full text
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07162506 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior surgery for esophageal cancer, radiotherapy, targeted therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage CT1N1-3M0 or CT2-4AN0-3M0 is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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