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

NCT07162506 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Esophageal Cancer

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

DRUG

Immunotherapy

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

Sponsors & Collaborators

  • Shanxi Province Cancer Hospital

    collaborator OTHER

  • Sichuan Province Cancer Hospital

    collaborator UNKNOWN

  • Henan Province Cancer Hospital

    collaborator UNKNOWN

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Wencheng Zhang, M.D. · Tianjin Cancer Hospital

  • Xiaofeng Duan, M.D. · Tianjin Cancer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-03
Primary Completion
2027-08-30
Completion
2030-08-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07162506 on ClinicalTrials.gov