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Trial Title:
Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy
NCT ID:
NCT06602843
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Conditions: Keywords:
Esophageal Squamous Cell Carcinoma
Locally advanced
Chemoimmunotherapy
Radioimmunotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Description:
Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Arm group label:
Comparator
Arm group label:
Experimental
Summary:
The goal of this study was to explore the efficacy and safety of neoadjuvant
chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy in patients
with locally advanced esophageal squamous cell carcinoma
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Ages 18-75;
- Radical operation for esophageal cancer;
- Esophageal squamous cell carcinoma was confirmed by postoperative pathology; .
Preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and
postoperative pathological evaluation were performed, and the stage was pIIB-IVA
(AJCC eighth edition staging criteria: T≥3 or N+).
- More than or equal to 12 lymph nodes were surgically removed;
- Postoperative ECOG score 0-1, able to tolerate postoperative adjuvant radiotherapy
and immunotherapy;
- Informed consent signed by patient or family member.
Exclusion Criteria:
- Less than 18 years old, more than 75 years old;
- did not receive radical resection of esophageal cancer, including palliative
resection;
- Postoperative pathology showed non-esophageal squamous cell carcinoma;
- After preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and
postoperative pathological evaluation, the stage was pI, IIA, IVB (AJCC eighth
edition staging standard); e. Less than 12 lymph nodes were surgically removed;
- Postoperative ECOG score 2-3 points, unable to tolerate postoperative adjuvant
radiotherapy and immunotherapy;
- The patient or family member did not sign the informed consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui provincial hospital
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuan He
Phone:
+8618926243766
Email:
heyuan3766@126.com
Start date:
January 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Source:
Anhui Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06602843
