The Efficacy of Surgical Treatment After Neoadjuvant Chemotherapy Plus Intraperitoneal Immunotherapy Versus Chemotherapy Alone for Patients With Positive Wash Cytology Gastric Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Phase II Clinical Trial: the Efficacy of Surgical Treatment in Combinations With Intraperitoneal Immunotherapy and Systemic Chemotherapy in Patients With Gastric Cancer and Verified Free Cancer Cells

Conditions
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Gastric Cancer, Metastatic

Intervention / Treatment
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* Procedure: neoadjuvant chemoimmunotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ECOG 0-2 Histologically proven gastric cancer T2-3 N+, T4a with any N (0,+) with free cancer cells in the abdominal cavity and no macroscopic canceromathosis and no other distant metastases (TNM classification 7th edition) Histological forms: gastric adenocarcinoma and signet ring cancer Blood characteristics (creatinine <150 mg/l, total bilirubin < 50 mkmol/l, neutrophils < 1500/mkl, hemoglobin >90 g/l, thrombocytes > 100000/mkl) Exclusion Criteria: Clinically apparent distant metastasis (besides free cancer cells) Synchronic or metachronic malignant tumors Previous systemic or surgical or combined therapy for gastric cancer Complications of gastric cancer (obstruction 0-1 GOOSS scale and/or gastric bleeding) Adhesions in abdominal cavity Gastrooesophageal junction cancer or gastric cancer with spreading on oesophagus.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neoadjuvant chemoimmunotherapy<br>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. | Procedure: neoadjuvant chemoimmunotherapy<br> <br> |
| No Intervention: neoadjuvant chemotherapy<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, metastatic, positive wash cytology, neoadjuvant intraperitoneal immunotherapy