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The purpose of this study is to determine whether intraperitoneal immunotherapy (with interleykin-2 - human cytokine reaction activator) with systemic chemotherapy will be more effective than systemic chemotherapy alone in patients with gastric cancer and verified free cancer cells in abdominal cavity in improving the long term outcomes and overall survival of further surgical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant chemoimmunotherapy | Experimental | Patients with gastric cancer and verified free cancer cells who receive 1 course of intraperitoneal immunotherapy with interleykin-2 + 3 courses of systemic chemotherapy (Cisplatin + 5-FU). In case of downstaging (M1 -> M0) surgical treatment will be performed. |
|
| neoadjuvant chemotherapy | No Intervention | Patients with gastric cancer and verified free cancer cells who receive 3 courses of systemic chemotherapy (Cisplatin + 5-FU). In case of downstaging (M1 -> M0) surgical treatment will be performed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neoadjuvant chemoimmunotherapy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall 2-year survival | Overall 2-year survival for patients who received radical (R0) surgical treatment after downstaging (M1 -> M0; Cyt "+" -> Cyt "-") with initial free cancer cells in the abdominal cavity without macroscopic canceromathosis. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Portability of the systemic therapy methods | Portability of the systemic therapy methods (intraperitoneal immunotherapy and systemic chemotherapy). Toxicity scale. | 6,9,12,24 months |
| Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Igor Khatkov, Professor, PhD | Contact | i.hatkov@mknc.ru | ||
| Roman Izrailov, Professor, PhD | Contact | r.izrailov@mknc.ru |
| Name | Affiliation | Role |
|---|---|---|
| Nikolay Semenov | Moscow Clinical Scientific Center | Principal Investigator |
| Boris Pomortsev | Moscow Clinical Scientific Center | Principal Investigator |
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Mortality related to intraperitoneal immunotherapy and systemic chemotherapy It is defined as the death within 24 months from the start of the treatment regardless of the reason.
| 24 months |
| Downstaging tumor | Number of patients that were downstaged (M1 -> M0; Cyt "+" -> Cyt "-") with initial free cancer cells in the abdominal cavity without macroscopic canceromathosis. | 2 years |
| Morbidity | Number of postoperative morbidity and mortality in the early post-operative period (for patients who received radical (R0) surgical treatment after downstaging) | 30 days |
| Quality of life | Quality of life ECOG scale. | 6, 12, 18, 24 months |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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