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RECRUITING
NCT07162506
PHASE2

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

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.

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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-11-03

Completion Date

2030-08-30

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

PROCEDURE

Surgery

Esophagectomy with systematic lymphadenectomy.

RADIATION

Radiotherapy

Radiotherapy: 50.4 Gy/28f

DRUG

Chemotherapy

Chemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles

DRUG

Immunotherapy

Camrelizumab consolidation therapy (200mg q21d) up to 1 year.

Locations (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China