Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy
NCT ID: NCT06602843
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2024-01-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Experimental
Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Comparator
chemoradiotherapy followed by surgery
Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Interventions
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Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Anhui Provincial Hospital
OTHER_GOV
Responsible Party
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Locations
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Anhui provincial hospital
Hefei, , China
Countries
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Facility Contacts
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Other Identifiers
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2024-042
Identifier Type: -
Identifier Source: org_study_id
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