NCT02976142

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2016

Typical duration for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

1.9 years

First QC Date

November 24, 2016

Last Update Submit

December 12, 2016

Conditions

Gastric Cancer, Metastatic

Keywords

gastric cancer, metastaticpositive wash cytologyneoadjuvant intraperitoneal immunotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Portability of the systemic therapy methods

    6,9,12,24 months

  • Mortality

    24 months

  • Downstaging tumor

    2 years

  • Morbidity

    30 days

  • Quality of life

    6, 12, 18, 24 months

Study Arms (2)

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.

Procedure: neoadjuvant chemoimmunotherapy

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.

Interventions

neoadjuvant chemoimmunotherapyPROCEDURE
neoadjuvant chemoimmunotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nikolay Semenov

    Moscow Clinical Scientific Center

    PRINCIPAL INVESTIGATOR

  • Boris Pomortsev

    Moscow Clinical Scientific Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Igor Khatkov, Professor, PhD

CONTACT

i.hatkov@mknc.ru

Roman Izrailov, Professor, PhD

CONTACT

r.izrailov@mknc.ru

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2016

First Posted

November 29, 2016

Study Start

December 1, 2016

Primary Completion

November 1, 2018

Study Completion

December 1, 2020

Last Updated

December 13, 2016

Record last verified: 2016-12