Efficacy and Survival Analysis of Perioperative Treatment of Locally Advanced Gastric or Gastroesophageal Junction Cancer (GC/GEJC)
Efficacy and Survival Prognosis Analysis of Perioperative Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100021
- Cancer Hodpital, Chinese Academy of Medical Sciences and Peking Union Medical College
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- (1) Pathologically diagnosed as gastric adenocarcinoma or esophageal-gastric junction adenocarcinoma, and has not received any anti-tumor treatment before (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.)
- (2) cT3-4N+M0 (according to AJCC version 8 stage) confirmed as resectable by CT or MRI.
- (3) Patients who underwent adjuvant therapy before surgery.
- (4) After neoadjuvant therapy , radical resection was performed at the Cancer Hospital of the Chinese Academy of Medical Sciences.
- (5) Patients who have complete clinical, pathological and imaging data.
Exclusion Criteria:
- (1) It is known that peritoneal metastasis or peritoneal irrigation solution cytology is positive (CY1P0) or there is distant metastasis (according to the 8th edition of AJCC).
- (2) There are unresectable factors, including irresectable tumor causes or surgical contraindications that are irresectable or refuse surgery.
- (3) Those who have suffered from other malignant tumors within 5 years or at the same time, except for cured skin basal cell carcinoma and cervical cancer in situ and breast cancer in situ.
- (4) Those who have had radiotherapy, interventional treatment and other local therapists before surgery.
- (5) Patients whose key diagnosis and treatment information records were missing.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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chemotherapy
patients who only used chemotherapy during neoadjuvant treatment
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Patients who only used chemotherapy during neodajuvant treatment period
Other Names:
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immunochemotherapy
patients who used immunotherapy combined with chemotherapy during neoadjuvant treatment
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Patients who used immunotherapy combined with chemotherapy during neodajuvant treatment period
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
OS
Time Frame: From the start date of cycle 1 (each cycle is 14 days or 21 days) neoadjuvant therapy until the date of first documented death from any cause, assessed up to 100 months.
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overall survival
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From the start date of cycle 1 (each cycle is 14 days or 21 days) neoadjuvant therapy until the date of first documented death from any cause, assessed up to 100 months.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EFS
Time Frame: From the start date of cycle 1 (each cycle is 14 days or 21 days) neoadjuvant therapy until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 100 months.
|
event free survival
|
From the start date of cycle 1 (each cycle is 14 days or 21 days) neoadjuvant therapy until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 100 months.
|
|
DFS
Time Frame: From the start date of cycle 1 (each cycle is 14 days or 21 days) adjuvant therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
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disease free survival
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From the start date of cycle 1 (each cycle is 14 days or 21 days) adjuvant therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- NCC5964
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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