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The purpose of this observational study is to evaluate the impact of different neoadjuvant therapies on patients with locally advanced gastric cancer. The primary question it aims to address is: Which patient populations benefit most from neoadjuvant immunochemotherapy versus neoadjuvant chemotherapy in locally advanced gastric cancer?
This study aims to: 1. Compare pCR rates and TRG between neoadjuvant chemotherapy (two-drug vs. three-drug) and neoadjuvant immunochemotherapy; 2. Explore efficacy differences across subgroups; 3. Provide evidence-based guidance for individualized neoadjuvant treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant chemotherapy | The nCT group included two subgroups: nCT2 (SOX/XELOX) and nCT3 (FLOT: docetaxel 50mg/m² + oxaliplatin 85mg/m² + leucovorin 200mg/m² d1 + fluorouracil 2600mg/m² 48h CIV q2w; or DCF: docetaxel 75mg/m² + cisplatin 75mg/m² d1 + fluorouracil 750mg/m² d1-5 q3w). |
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| neoadjuvant immunochemotherapy | The nICT group received PD-1 inhibitors (sintilimab 200mg, tislelizumab 200mg, or nivolumab 240mg, all iv q3w) combined with two-drug chemotherapy (SOX: oxaliplatin 130mg/m² d1 + S-1 40-60mg bid d1-14; or XELOX: oxaliplatin 130mg/m² d1 + capecitabine 1000mg/m² bid d1-14, both q3w). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy | Drug | The nICT group received PD-1 inhibitors (sintilimab 200mg, tislelizumab 200mg, or nivolumab 240mg, all iv q3w) combined with two-drug chemotherapy (SOX: oxaliplatin 130mg/m² d1 + S-1 40-60mg bid d1-14; or XELOX: oxaliplatin 130mg/m² d1 + capecitabine 1000mg/m² bid d1-14, both q3w). The nCT group included two subgroups: nCT2 (SOX/XELOX) and nCT3 (FLOT: docetaxel 50mg/m² + oxaliplatin 85mg/m² + leucovorin 200mg/m² d1 + fluorouracil 2600mg/m² 48h CIV q2w; or DCF: docetaxel 75mg/m² + cisplatin 75mg/m² d1 + fluorouracil 750mg/m² d1-5 q3w). |
| Measure | Description | Time Frame |
|---|---|---|
| PCR | Pathological complete response | 2019.11-2023.12 |
| TRG | tumor regression grade | 2019.11-2023.12 |
| Measure | Description | Time Frame |
|---|---|---|
| OS | overall survival | 2019.11-2023.12 |
| EFS | event-free survival | 2019.11-2023.12 |
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Inclusion Criteria:
Eligible patients had pathologically confirmed adenocarcinoma, imaging-confirmed resectable LAGC (cT2-4aN0-3M0, AJCC 8th), no distant metastases, and completed protocol-specified neoadjuvant therapy (nICT: PD-1/PD-L1 inhibitors plus two-drug chemotherapy; nCT: two-drug [SOX/XELOX] or three-drug [FLOT/DCF] chemotherapy) with ECOG 0-1.
Exclusion Criteria:
Exclusion criteria included incomplete neoadjuvant therapy, non-radical surgery, other malignancies, active autoimmune diseases/immunosuppressant use, missing key data, or inadequate follow-up (<3 months without documented events).
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This study screened 10,334 patients diagnosed with gastric/gastroesophageal junction tumors at a tertiary-grade A cancer hospital from November 2019 to December 2023 , identifying 777 who received neoadjuvant therapy, with 291 meeting inclusion criteria for final analysis. The cohort comprised resectable gastric adenocarcinoma patients undergoing neoadjuvant immunochemotherapy (nICT, n=98) or chemotherapy (nCT, n=193) followed by radical surgery (Figure S1), with follow-up through November 2024.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| C000632826 | sintilimab |
| C000707970 | tislelizumab |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
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|
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D000911 |
| Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |