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Neoadjuvant Immunochemotherapy vs Chemoradiotherapy in ESCC

NCT07236320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-11-19

No results posted yet for this study

Summary

This retrospective real-world study aimed to compare neoadjuvant immunochemotherapy (NICT) and neoadjuvant chemoradiotherapy (NCRT) followed by esophagectomy in patients with locally advanced esophageal squamous cell carcinoma (ESCC). A total of 203 consecutive patients treated at Sichuan Cancer Hospital between March 2018 and March 2022 were analyzed (NICT: 59; NCRT: 144). The primary endpoints were overall survival (OS) and disease-free survival (DFS); secondary endpoints included pathological complete response (pCR), tumor regression grade (TRG), and R0 resection rate. After inverse probability of treatment weighting adjustment, baseline characteristics were balanced between groups. Both groups achieved comparable long-term OS and DFS, while NCRT showed higher rates of local pathological response. Exploratory subgroup analysis suggested that patients achieving pCR after NICT might have superior survival outcomes. The study indicates that NICT provides similar long-term survival compared to NCRT and may offer immunologic advantages for selected responders, warranting further validation in prospective multicenter trials.

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

DRUG

Neoadjuvant immunochemotherapy

NACI group patients received treatment of minimally 2 cycles of ICIs agent (mainly camrelizumab or toripalimab, 200 mg every 3 weeks (200 mg every 3 weeks)) combined with concurrent chemotherapy.

DRUG

Neoadjuvant Chemoradiotherapy

NCRT group patients followed the concurrent NCRT treatment, and the total neoadjuvant radiotherapy dose was 40.0-50.4Gy with 1.8-2.14 Gy fractions and 5 fractions/week.

Sponsors & Collaborators

  • Yongtao Han

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2022-03-31
Completion
2025-02-28

Countries

  • China

Study Locations

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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 NCT07236320 on ClinicalTrials.gov