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

Moscow Clinical Scientific Center

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer, Metastatic

Treatments: Procedure: neoadjuvant chemoimmunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02976142

MKNC02/2016

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

neoadjuvant chemoimmunotherapy

Experimental group

Description:

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.

Treatment:

Procedure: neoadjuvant chemoimmunotherapy

neoadjuvant chemotherapy

No Intervention group

Description:

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.