The Effect of Immunological Heterogeneity of Tumor Microenvironment in the Prognosis of Gastric Cancer

NCT04819958 | Unknown DMC

• 1 other identifier: FUGES-B01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the effect of immunological heterogeneity of tumor microenvironment in the short-term outcome and long-term outcome of patients with gastric cancer.

Conditions

Stomach Cancer

Outcome Measures

Primary Outcomes (1)

• 3-year disease free survival rate

  3-year disease free survival rate

  36 months

Secondary Outcomes (14)

• 3-year overall survival rate

  36 months

• Morbidity rates

  30 days

• Mortality rates

  30 days

• Total number of retrieved lymph nodes

  One month after surgery

• Intraoperative morbidity rates

  1 day

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are assigned to undergo gastrectomy for gastric cancer are included.

You may qualify if:

• Age from 18 to 80 years
• Histology confirmed gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy.
• Clinical stage: cTNM: stage I or above at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition
• Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)
• Clinically fit for gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
• Written informed consent

You may not qualify if:

• Women during pregnancy or breast-feeding
• Severe mental disorder
• History of previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection
• History of other malignant diseases within the past five years
• History of unstable angina or myocardial infarction within the past six months
• History of a cerebrovascular accident within the past six months
• History of continuous systematic administration of corticosteroids within one month
• Requirement of simultaneous surgery for other diseases
• Emergency surgery due to complication (bleeding, obstruction, or perforation) caused by gastric cancer
• Forced expiratory volume in 1 second (FEV1)\<50% of predicted values

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Department of Gastric Surgery

Fuzhou, Fujian, China

RECRUITING

Related Publications (6)

• Kumagai S, Togashi Y, Kamada T, Sugiyama E, Nishinakamura H, Takeuchi Y, Vitaly K, Itahashi K, Maeda Y, Matsui S, Shibahara T, Yamashita Y, Irie T, Tsuge A, Fukuoka S, Kawazoe A, Udagawa H, Kirita K, Aokage K, Ishii G, Kuwata T, Nakama K, Kawazu M, Ueno T, Yamazaki N, Goto K, Tsuboi M, Mano H, Doi T, Shitara K, Nishikawa H. The PD-1 expression balance between effector and regulatory T cells predicts the clinical efficacy of PD-1 blockade therapies. Nat Immunol. 2020 Nov;21(11):1346-1358. doi: 10.1038/s41590-020-0769-3. Epub 2020 Aug 31.

  PMID: 32868929 BACKGROUND

• Smyth EC, Nilsson M, Grabsch HI, van Grieken NC, Lordick F. Gastric cancer. Lancet. 2020 Aug 29;396(10251):635-648. doi: 10.1016/S0140-6736(20)31288-5.

  PMID: 32861308 BACKGROUND

• Utzschneider DT, Gabriel SS, Chisanga D, Gloury R, Gubser PM, Vasanthakumar A, Shi W, Kallies A. Early precursor T cells establish and propagate T cell exhaustion in chronic infection. Nat Immunol. 2020 Oct;21(10):1256-1266. doi: 10.1038/s41590-020-0760-z. Epub 2020 Aug 24.

  PMID: 32839610 BACKGROUND

• Gao Y, Nihira NT, Bu X, Chu C, Zhang J, Kolodziejczyk A, Fan Y, Chan NT, Ma L, Liu J, Wang D, Dai X, Liu H, Ono M, Nakanishi A, Inuzuka H, North BJ, Huang YH, Sharma S, Geng Y, Xu W, Liu XS, Li L, Miki Y, Sicinski P, Freeman GJ, Wei W. Acetylation-dependent regulation of PD-L1 nuclear translocation dictates the efficacy of anti-PD-1 immunotherapy. Nat Cell Biol. 2020 Sep;22(9):1064-1075. doi: 10.1038/s41556-020-0562-4. Epub 2020 Aug 24.

  PMID: 32839551 BACKGROUND

• Salgia NJ, Bergerot PG, Maia MC, Dizman N, Hsu J, Gillece JD, Folkerts M, Reining L, Trent J, Highlander SK, Pal SK. Stool Microbiome Profiling of Patients with Metastatic Renal Cell Carcinoma Receiving Anti-PD-1 Immune Checkpoint Inhibitors. Eur Urol. 2020 Oct;78(4):498-502. doi: 10.1016/j.eururo.2020.07.011. Epub 2020 Aug 19.

  PMID: 32828600 BACKGROUND

• Tumeh PC, Harview CL, Yearley JH, Shintaku IP, Taylor EJ, Robert L, Chmielowski B, Spasic M, Henry G, Ciobanu V, West AN, Carmona M, Kivork C, Seja E, Cherry G, Gutierrez AJ, Grogan TR, Mateus C, Tomasic G, Glaspy JA, Emerson RO, Robins H, Pierce RH, Elashoff DA, Robert C, Ribas A. PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature. 2014 Nov 27;515(7528):568-71. doi: 10.1038/nature13954.

  PMID: 25428505 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

the resected specimens with DNA

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Changming Huang, MD

CONTACT

+8613805069676; hcmlr2002@163.com

Qing Zhong

CONTACT

+8615859634839; 845733977@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Department of Gastric Surgery, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: March 31, 2021
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)