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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02976142

Enrollment

150

Registered

2016-11-29

Start date

2016-12-31

Completion date

2020-12-31

Last updated

2016-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Metastatic

Keywords

gastric cancer, metastatic, positive wash cytology, neoadjuvant intraperitoneal immunotherapy

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.

Interventions

PROCEDUREneoadjuvant chemoimmunotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Portability of the systemic therapy methods	6,9,12,24 months	Portability of the systemic therapy methods (intraperitoneal immunotherapy and systemic chemotherapy). Toxicity scale.
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.
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.
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)
Quality of life	6, 12, 18, 24 months	Quality of life ECOG scale.

Contacts

Primary ContactIgor Khatkov, Professor, PhD

i.hatkov@mknc.ru

Backup ContactRoman Izrailov, Professor, PhD

r.izrailov@mknc.ru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026