Different Cycles of Neoadjuvant PD-1 Blockades + Chemotherapy for Advanced Gastric Cancer
NCT ID: NCT06798376
Last Updated: 2025-01-29
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
300 participants
OBSERVATIONAL
2025-01-16
2025-01-31
Brief Summary
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* Does the duration of neoadjuvant treatment influence tumor regression grading (TRG)?
* How does treatment duration affect perioperative safety and clinical outcomes?
Participants who have previously undergone neoadjuvant PD-1 inhibitor combined with chemotherapy followed by surgery as part of their routine medical care will have their clinical data retrospectively reviewed and analyzed.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Group A
The group A contains participants who received ≤4 cycles of neoadjuvant PD-1 inhibitor combined with chemotherapy and then received gastrectomy.
≤4 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy
Any PD-1 inhibitors combined with any chemotherapy regimen given before surgery for no more than 4 cycles
Gastrectomy
Any type of surgical procedure for gastric adenocarcinoma patients in which part or all of the stomach is removed
Group B
The group B contains participants who received ≥5 cycles of neoadjuvant PD-1 inhibitor combined with chemotherapy and then received gastrectomy.
≥5 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy
Any PD-1 inhibitors combined with any chemotherapy regimen given before surgery for no less than 5 cycles
Gastrectomy
Any type of surgical procedure for gastric adenocarcinoma patients in which part or all of the stomach is removed
Interventions
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≤4 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy
Any PD-1 inhibitors combined with any chemotherapy regimen given before surgery for no more than 4 cycles
≥5 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy
Any PD-1 inhibitors combined with any chemotherapy regimen given before surgery for no less than 5 cycles
Gastrectomy
Any type of surgical procedure for gastric adenocarcinoma patients in which part or all of the stomach is removed
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed gastric or gastroesophageal junction adenocarcinoma by biopsy;
* Evaluated as resectable advanced gastric cancer via CT, MRI, or laparoscopic exploration;
* No prior anti-tumor treatments such as chemotherapy, radiotherapy, or immunotherapy;
* No history of other malignancies within the past 5 years;
* Received at least one cycle of PD-1 inhibitor combined with chemotherapy preoperatively, with no restrictions on the specific PD-1 inhibitor or chemotherapeutic agents;
* Underwent radical gastrectomy after neoadjuvant therapy;
* No severe underlying diseases.
Exclusion Criteria
* Postoperative pathology confirming non-gastric or non-gastroesophageal junction adenocarcinoma;
* Distant metastases present prior to treatment;
* Concurrent diagnosis of other malignancies.
18 Years
90 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Xinxin Wang
Prof.
Locations
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Chinese PLA General Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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S2024-823
Identifier Type: -
Identifier Source: org_study_id
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