RecruitingPhase 2NCT07162506

DCRT vs. Surgery in Resectable ESCC Patient Achiving cCR/PR After nCI

Definitive Concurrent Chemoradiotherapy Versus Surgery in Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma (ESCC) Who Achieve Complete or Partial Response After Neoadjuvant Chemo-immunotherapy: A Two-arm Phase II Clinical Study (SORT Trial)

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

120 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer

Summary

This is a multi-center, Phase II clinical study aiming to evaluate the efficacy, safety, and organ preservation feasibility of definitive concurrent chemoradiotherapy versus surgery in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) who achieve clinical complete response/partial response (cCR/PR) after neoadjuvant chemo-immunotherapy. A total of 120 eligible subjects will be enrolled. Patients with cCR/PR after 2 cycles of neoadjuvant chemo-immunotherapy will be grouped based on personal willing: the control group (n=60) will receive radical esophagectomy + mediastinal lymph node dissection; the experimental group (n=60) will receive definitive concurrent chemoradiotherapy (radiotherapy: 50.4 Gy/28f; chemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles). All the patients will receive camrelizumab maintenance therapy (200mg q21d) up to 1 year.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for people with locally advanced esophageal squamous cell cancer (a type of cancer in the food pipe) who responded well to initial chemotherapy: continued chemoradiation therapy versus surgery. The goal is to find out which approach provides better outcomes when the initial treatment has already shrunk the tumor significantly. **You may be eligible if...** - You are 18 to 75 years old - You have confirmed locally advanced esophageal squamous cell cancer (stages II–IVa) - Your tumor responded (partially or fully) to 2 rounds of chemotherapy with camrelizumab plus chemotherapy drugs - You are in good enough health (ECOG 0–1) for either treatment - Your life expectancy is at least 3 months **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - Your organ function does not meet the required thresholds - You cannot give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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