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

NCT03493880 | Unknown

• 1 other identifier: INdex
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Pathological response

  Pathological response

  One month after surgery

Secondary Outcomes (4)

• 3-years overall survival

  Three years after surgery

• 3-years disease-free survival

  Three years after surgery

• Postoperative morbidity

  One month after surgery

• yp TNM Stage

  One month after surgery

Study Arms (2)

naCT

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

naCRT

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Lack of immuno-nutrition data

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Jiafu Ji, M.D., Ph.D.

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuangxi Li, M.D., Ph.D.

CONTACT

lishx@hsc.pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Surgeon

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 11, 2018
• Study Start: September 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2025
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

CN (1)