Gastric Cancer, MetastaticPhase 2NCT02976142
The Efficacy of Surgical Treatment After Neoadjuvant Chemotherapy Plus Intraperitoneal Immunotherapy Versus Chemotherapy Alone for Patients With Positive Wash Cytology Gastric Cancer
A Phase 2 study testing neoadjuvant chemoimmunotherapy in people with Gastric Cancer, Metastatic, run by Moscow Clinical Scientific Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Metastatic
- What is being tested?
- neoadjuvant chemoimmunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
No sites are listed yet.
Igor Khatkov, Professor, PhD contact
Roman Izrailov, Professor, PhD contact
About this study
Official title: 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
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.
- Conditions
- Gastric Cancer, Metastatic
- Being tested
- neoadjuvant chemoimmunotherapy
- Keywords
- gastric cancer, metastatic, positive wash cytology, neoadjuvant intraperitoneal immunotherapy
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemoimmunotherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (5)
Portability of the systemic therapy methods
Portability of the systemic therapy methods (intraperitoneal immunotherapy and systemic chemotherapy). Toxicity scale.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 30 days
Quality of life
Quality of life ECOG scale.
Measured: 6, 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionNov 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer, MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow Clinical Scientific Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolay Semenov, Principal investigator, Moscow Clinical Scientific CenterBoris Pomortsev, Principal investigator, Moscow Clinical Scientific Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976142
- Sponsor's protocol ID
- MKNC02/2016
- Status last verified
- Dec 2016
- First submitted
- 24 Nov 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02976142
- Acronym / sponsor ID
- MKNC02/2016
- Conditions
- Gastric Cancer, Metastatic
- Keywords
- gastric cancer, metastatic, positive wash cytology, neoadjuvant intraperitoneal immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Moscow Clinical Scientific CenterUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant chemoimmunotherapy | Experimental | Procedure: neoadjuvant chemoimmunotherapyPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoadjuvant chemoimmunotherapy | Procedure or surgery | neoadjuvant chemoimmunotherapy |
Primary outcome
Overall 2-year survival
Time frame: 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.
5 secondary outcomes
Portability of the systemic therapy methods
Time frame: 6,9,12,24 months
Mortality
Time frame: 24 months
Downstaging tumor
Time frame: 2 years
Morbidity
Time frame: 30 days
Quality of life
Time frame: 6, 12, 18, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Khatkov, Professor, PhD contact
Roman Izrailov, Professor, PhD contact
Nikolay Semenov principal investigator
Moscow Clinical Scientific Center
Boris Pomortsev principal investigator
Moscow Clinical Scientific Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing neoadjuvant chemoimmunotherapy in people with Gastric Cancer, Metastatic, run by Moscow Clinical Scientific Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Igor Khatkov, Professor, PhD (i.hatkov@mknc.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall 2-year survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.