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The aim of this study is to test the efficacy and safety of immunotherapy plus chemotherapy on people with a relatively rare type of gastric cancer. Participants will take the anti-PD-1 inhibitor (Tislelizumab) and platinum-based chemotherapy (oxaliplatin + capecitabine or oxaliplatin + S-1) in a 3-week cycle, followed by a radical operation after 6 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab + SOX/XELOX | Experimental | Patients with borrmann type 4 or large type 3 (over 8 cm) gastric cancer, who are deemed to be surgically resectable, are treated with neoadjuvant Tislelizumab (200 mg) and oxaliplatin (150 mg) intravenously on day 1 plus capecitabine (2500 mg) or S-1 (40 mg) orally on day 1-14 in each 21-day cycle. Radical gastrectomy will be performed after 6 cycles, followed by adjuvant chemotherapy (capecitabine or S-1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab 200 mg will be administered systemically on day 1 of each cycle in all participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| MPR | Major pathologic response, defined as less than 10% residual tumor following neoadjuvant therapy | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | up to 2 years | |
| Incidence of surgical complications | up to 2 years | |
| Rate of R0 resection |
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Inclusion Criteria:
Histologically confirmed gastric adenocarcinoma,cT1-2N+M0 or cT3-4NanyM0;
Males or females, aged 18-70 years;
Gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (borrmann type 4) or large type 3 (over 8 cm);
No peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;
ECOG performance status 0 or 1;
Sufficient organ function:
No prior anti-tumor therapy;
Have signed informed consent before the beginning of treatment.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haibo Qiu, MD, Ph.D | Contact | 020-87343910 | qiuhb@sysucc.org.cn | |
| Chao Ding, MD, Ph.D | Contact | 020-87343123 | dingchao@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Haibo Qiu, MD, Ph.D | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510010 | 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 |
|---|---|
| C000707970 | tislelizumab |
| D000077150 | Oxaliplatin |
| C079198 | S 1 (combination) |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
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| Oxaliplatin | Drug | Oxaliplatin 150 mg will be administered systemically on day 1 of each cycle in all participants |
|
| S-1 | Drug | S-1 40 mg will be administered orally on day 1-14 of each cycle in all participants |
|
| Capecitabine | Drug | Capecitabine 2500 mg will be administered orally on day 1-14 of each cycle in all participants |
|
| up to 2 years |
| OS | 3-year overal survival | up to 5 years |
| DFS | 3-year disease-free survival | up to 5 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |