NCT07236320

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

4.1 years

First QC Date

November 15, 2025

Last Update Submit

November 15, 2025

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Outcome Measures

Primary Outcomes (2)

  • Overall Survival (OS)

    Time from first treatment to death from any cause or last follow-up.

    5 years

  • Disease-Free Survival (DFS)

    Time from surgery to recurrence, death, or last follow-up.

    5 years

Secondary Outcomes (3)

  • Pathological Complete Response (pCR) rate

    3 months

  • Tumor Regression Grade (TRG)

    3 months

  • R0 resection rate

    3 months

Study Arms (2)

NICT group

EXPERIMENTAL
Drug: Neoadjuvant immunochemotherapy

NCRT group

ACTIVE COMPARATOR
Drug: Neoadjuvant Chemoradiotherapy

Interventions

Neoadjuvant immunochemotherapyDRUG

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.

NICT group
Neoadjuvant ChemoradiotherapyDRUG

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.

NCRT group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80 years
  • Histologically confirmed thoracic ESCC
  • Clinical stage cT1N+M0 or cT2-4aN0-3M0
  • Received neoadjuvant therapy (immunochemotherapy or chemoradiotherapy) followed by esophagectomy

You may not qualify if:

  • History of other malignancies
  • Did not complete neoadjuvant therapy or required salvage surgery
  • Incomplete baseline or follow-up data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Cancer Hospital and Institute

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Surgeon / Professor, Department of Thoracic Surgery

Study Record Dates

First Submitted

November 15, 2025

First Posted

November 19, 2025

Study Start

March 1, 2018

Primary Completion

March 31, 2022

Study Completion

February 28, 2025

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

CN(1)