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RECRUITING
NCT07162506
PHASE2

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-08-01

Completion Date

2030-08-30

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

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

Locations (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China