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

Phase 2

• Conditions: Gastric Cancer, Metastatic
• Interventions: Procedure: neoadjuvant chemoimmunotherapy

• Registration Number: NCT02976142
• Lead Sponsor: Moscow Clinical Scientific Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-29
• Status Verified: 2016-12
• Study Start: 2016-12
• Last Update Submitted: 2016-12-12
• Last Update Posted: 2016-12-13
• Primary Completion: 2018-11
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
neoadjuvant chemoimmunotherapy	neoadjuvant chemoimmunotherapy	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.

Primary Outcome Measures

Name	Time	Method
Overall 2-year survival	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Mortality	24 months	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.
Portability of the systemic therapy methods	6,9,12,24 months	Portability of the systemic therapy methods (intraperitoneal immunotherapy and systemic chemotherapy). Toxicity scale.
Downstaging tumor	2 years	Number of patients that were downstaged (M1 -\> M0; Cyt "+" -\> Cyt "-") with initial free cancer cells in the abdominal cavity without macroscopic canceromathosis.
Quality of life	6, 12, 18, 24 months	Quality of life ECOG scale.
Morbidity	30 days	Number of postoperative morbidity and mortality in the early post-operative period (for patients who received radical (R0) surgical treatment after downstaging)