NCT07162506

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 Camrelizumab Combined With Chemotherapy: A Two-arm Phase II Clinical Study (SORT Trial)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-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 camrelizumab combined with chemotherapy. A total of 120 eligible subjects will be enrolled. Patients with cCR/PR after 2 cycles of induction chemoimmunotherapy (camrelizumab + nab-paclitaxel + carboplatin) 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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
PROCEDURE	Surgery	Radical esophagectomy + mediastinal lymph node dissection
RADIATION	Radiotherapy	Radiotherapy: 50.4 Gy/28f
DRUG	Chemotherapy	Chemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-08-30
• Completion: 2030-08-30
• First posted: 2025-09-09
• Last updated: 2026-02-04

Locations

1 site across 1 country: China