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Clinical Trials/NCT06472635
NCT06472635
Active, not recruiting
Not Applicable

A Retrospective, Multicenter, Single-arm Real-world Study on a New Adjuvant Chemotherapy Combined With Immune Inhibitors for Resectable Esophageal Squamous Cell Carcinoma (ESCC)

Zhejiang University1 site in 1 country95 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
The Neoadjuvant Treatment for Resectable Esophageal Squamous Cell Carcinoma
Sponsor
Zhejiang University
Enrollment
95
Locations
1
Primary Endpoint
Pathological Complete Response (pCR)
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

Research Purpose 1: To evaluate the therapeutic efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 2: To analyze the influencing factors of the therapeutic effect of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 3: To understand the treatment patterns of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced ESCC in the

Detailed Description

Research Purpose 1: To evaluate the therapeutic efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting. Research Purpose 2: To analyze the influencing factors of the therapeutic effect of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting. Research Purpose 3: To understand the treatment patterns of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced ESCC in the

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
October 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Zhejiang University
Responsible Party
Principal Investigator
Principal Investigator

Zhengliang.Tu

Director of General Thoracic Surgery Department / Chief Doctor

Zhejiang University

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years (including 18 years old); ECOG 0 or 1; Patients with esophageal squamous cell carcinoma judged to be resectable (including initially non-resectable) by the researcher Received esophageal radical surgery and neoadjuvant immune chemotherapy before surgery Clinical staging belongs to: T1b-4NanyM0;

Exclusion Criteria

  • Patients without complete medical information; Received other anti-tumor treatment before surgery; Received radiotherapy treatment; Judged by the researcher, have other conditions unsuitable for participating in this clinical study.
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Outcomes

Primary Outcomes

Pathological Complete Response (pCR)

Time Frame: 12 months

pCR is defined as the ratio of residual viable tumor cells being 0 in the primary tumor and sampled lymph nodes.

Secondary Outcomes

  • Resection Rate(12 months)

Study Sites (1)

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