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RecruitingNCT03493880Updated Apr 11, 2018

The Analysis of Immuno-Nutrition Index in Advanced Gastric Cancer Receiving Preoperative Treatments

An observational study in Gastric Cancer, Neoadjuvant Chemotherapy and Neoadjuvant Chemoradiotherapy, sponsored by Peking University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2018-04-11.

Sponsored by Peking University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2020, 6 years 2 months ago, but the record still lists the study as recruiting.
  • Started Sep 2015; still recruiting 11 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 43 studies in Stomach Neoplasms by Peking University — 10 open to participants now, 11 under way, none of them phase 3. Stomach Neoplasms · Peking University.

Planned enrollment
4th of 14
600 · median 300
Started
2015
with 2 others
Observational
14 of 43
5 open now
Primary completion
2020-09
later than 0 of 10 live
Registered
23rd of 43
by date

Among the 43 studies in Stomach Neoplasms by Peking University, this one is the 4th largest by planned enrollment of the 14 observational ones, is one of 3 that started in 2015, is one of 14 observational ones, reaches primary completion later than 0 of the 10 other live ones, and was the 23rd registered.

By phase

43 studies; the count open now beside each. This study's row is marked.

Phase 216 · 3 open
Observationalthis study14 · 5 open
No phase8 · 1 open
Phase 33 · 0 open
Phase 12 · 1 open

By the year they started

First in 2007; this study’s year is marked. 3 started in 2015.

Size and results

Median enrollment 64 across the 29 interventional studies, 300 across the 14 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.

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02

Study summary

Based on multiple studies, the immune (systemic inflammation) and nutrition index were correlated with short- and long-term prognosis for gastric cancer. With the increasing application of preoperative treatments (chemotherapy and chemoradiotherapy), the issues concerning how are the immuno-nutrition index be altered under the effects of perioperative treatments and what are the clinical values of these index should be clarified.

Read the detailed description

The immune (systemic inflammation) index includes:

NLR (Neutrophil-to-Lymphocyte Ratio); PLR (Platelet-to-Lymphocyte Ratio); SII (Systemic Immune-Inflammation Index); GPS (Glasgow Prognostic Score); mGPS (modified Glasgow Prognostic Score); PI (Prognostic Index);

The nutrition index includes:

NRS2002; PNI (Prognostic Nutrition Index);

03

Conditions studied

  • Gastric Cancer
  • Neoadjuvant Chemotherapy
  • Neoadjuvant Chemoradiotherapy
  • Systemic Inflammatory Response Syndrome (SIRS)
  • Nutrition Aspect of Cancer
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All the patients with advanced gastric cancer or esophagogastric cancer receiving neoadjuvant chemotherapy or chemoradiotherapy will be included for this observational study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed adenocarcinoma
  • Received (preoperative) chemotherapy or chemoradiotherapy
  • Diagnosed clinical advanced gastric cancer or esophagogastric cancer

Exclusion criteria

Exclusion Criteria:

  • Lack of immuno-nutrition data
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • naCT

    Advanced gastric cancer or esophagogastric cancer receiving neoadjuvant (preoperative) chemotherapy.

  • naCRT

    Advanced gastric cancer or esophagogastric cancer receiving neoadjuvant (preoperative) chemoradiotherapy.

06

What researchers measure

Primary outcomes

  1. Pathological response

    Pathological response

    Time frame: One month after surgery

Secondary outcomes

  1. 3-years overall survival

    3-years overall survival

    Time frame: Three years after surgery

  2. 3-years disease-free survival

    3-years disease-free survival

    Time frame: Three years after surgery

  3. Postoperative morbidity

    Postoperative morbidity

    Time frame: One month after surgery

  4. yp TNM Stage

    yp TNM Stage

    Time frame: One month after surgery

07

Study locations

1 of 1 sites recruiting
  • Peking University Cancer Hospital
    Beijing, Beijing 100142, China
    Recruiting
    • Shuangxi Li, M.D. · Contactlishx@hsc.pku.edu.cn
    • Jiafu Ji, M.D.,Ph.D. · Principal investigator
    • Ziyu Li, M.D.,Ph.D. · Principal investigator
    • Shuangxi Li, M.D.,Ph.D. · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2015 (actual). Primary completion is estimated for Sep 2020, 60 months after the start.

Of 322 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 171. This study's planned 60 months is close to that.

Counting every sponsor, half of 364 studies reached it within 54 months; a quarter within 29 and three quarters within 119.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2018
First posted
Apr 11, 2018
StartActual
Sep 1, 2015
Primary completionEst.
Sep 1, 2020
CompletionEst.
Sep 1, 2025
Last update
Apr 11, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03493880
Lead sponsor
Peking University
Responsible party
Shuang-xi Li (Associate Chief Surgeon, Peking University) — Principal investigator
First posted
Apr 11, 2018
Start date
Sep 1, 2015
Primary completion
Sep 1, 2020 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Apr 11, 2018

Study contacts

Shuangxi Li, M.D., Ph.D.
Contact
lishx@hsc.pku.edu.cn
Jiafu Ji, M.D., Ph.D.
principal investigator · Peking University Cancer Hospital & Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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