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Gastric cancer is one of the most common malignant tumors of the digestive tract. Gastric cancer patients diagnosed for the first time in China have a higher proportion of advanced stages and a higher postoperative metastasis rate.Studies have shown that patients with good pathological response after preoperative neoadjuvant therapy (such as tumor regression grade, TRG0 or 1) have a better prognosis.The purpose of this study is to treat patients with advanced gastric cancer who are difficult to perform R0 surgery with chemotherapy combined with immunotherapy. At the same time as the primary cancerous lesions are reduced, the distant metastatic lesions are effectively controlled in order to perform R0 surgery and to improve the survival rate of patients with advanced gastric cancer.
The interventions include camrelizumab and chemotherapy selected based on the use of different metastatic sites as conversion therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conversion therapy | Experimental | Camrelizumab combined with chemotherapy selected per metastasis site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | 200mg, intravenous drip administration, d1, every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | Defined as no residue under the microscope after resection | Within 1 month of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response | The number of people who have achieved complete pathological remission accounted for the proportion of people who met the plan. | Within 1 month of surgery. |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quan Quan, MD | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C079198 | S 1 (combination) |
| D000077150 | Oxaliplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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| S-1 | Drug | Oral, d1-14, every 3 weeks. |
|
|
| Oxaliplatin | Drug | 130mg/m² intravenous drip administration, d1, every 3 weeks(For patients with liver and/or para-aortic lymph node metastasis). |
|
| Paclitaxel | Drug | Intraperitoneal paclitaxel 20 mg/m² and intravenous paclitaxel 50 mg/m² on days 1 and 8, every 3 weeks(For patients with peritoneal metastasis ). |
|
The time from the start of system therapy to the death of any cause.
| From the start of system therapy to death from any cause. |
| 2-year survival rate | Percentage of subjects who are alive without death event at two years. | 2 years from the start of system therapy. |
| Adverse events(all grades) | Assessed per Common Terminology Criteria for Adverse Events(CTCAE) version 5.0 | From the start of system therapy to 6 months after surgery. |
| Serious adverse events(≥grade 3) | Assessed per Common Terminology Criteria for Adverse Events(CTCAE) version 5.0 | From the start of system therapy to 6 months after surgery. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |