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

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07162506
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Surgery — PROCEDURE
    Radical esophagectomy + mediastinal lymph node dissection
  • Radiotherapy — RADIATION
    Radiotherapy: 50.4 Gy/28f
  • Chemotherapy — DRUG
    Chemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles
  • Immunotherapy — DRUG
    Camrelizumab maintenance therapy (200mg q21d) up to 1 year.

Study Details

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 2-3 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.

Key Dates

First listed
Sep 9, 2025
Start date
Nov 3, 2025
Status verified
May 2026
Primary completion
Aug 30, 2027
Completion
Aug 30, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Surgery
    Radical esophagectomy + mediastinal lymph node dissection
  • Experimental: DCRT
    Definitive concurrent chemoradiotherapy (radiotherapy: 50.4 Gy/28f; chemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles)

Primary Outcome Measure

DFS [ Time Frame: up to 3 years ]

Central Contacts

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