Clinical Trials Directory

Trials / Completed

CompletedNCT07236320

Neoadjuvant Immunochemotherapy vs Chemoradiotherapy in ESCC

Neoadjuvant Immunochemotherapy Versus Chemoradiotherapy in Locally Advanced Esophageal Cancer: A Real-World Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
200 (actual)
Sponsor
Yongtao Han · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGNeoadjuvant immunochemotherapyNACI 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.
DRUGNeoadjuvant ChemoradiotherapyNCRT 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.

Timeline

Start date
2018-03-01
Primary completion
2022-03-31
Completion
2025-02-28
First posted
2025-11-19
Last updated
2025-11-19

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07236320. Inclusion in this directory is not an endorsement.