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

Stomach Cancer Clinical Trial

Official title:

The Effect of Immunological Heterogeneity of Tumor Microenvironment in the Short-term Outcome and Long-term Outcome of Patients With Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04819958
• Other study ID #: FUGES-B01
• Status: Recruiting
• Start date: March 31, 2021
• Est. completion date: August 30, 2021

Study information

• Verified date: April 2021
• Source: Fujian Medical University
• Contact: Changming Huang, MD
• Phone: +8613805069676
• Email: hcmlr2002[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

A prospective cohort study will be performed to explore the effect of immunological heterogeneity of tumor microenvironment in the short-term outcome and long-term outcome of patients with gastric cancer. The evaluation parameters are perioperative clinical efficacy, postoperative complications, and 3-year survival and recurrence rates.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age from 18 to 80 years

2. Histology confirmed gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy.

3. Clinical stage: cTNM: stage I or above at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition

4. Performance status: Eastern Cooperative Oncology Group (ECOG) = 2 (normal to symptomatic but in bed less than half the day)

5. Clinically fit for gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.

6. Written informed consent

Exclusion Criteria:

1. Women during pregnancy or breast-feeding

2. Severe mental disorder

3. History of previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection

4. History of other malignant diseases within the past five years

5. History of unstable angina or myocardial infarction within the past six months

6. History of a cerebrovascular accident within the past six months

7. History of continuous systematic administration of corticosteroids within one month

8. Requirement of simultaneous surgery for other diseases

9. Emergency surgery due to complication (bleeding, obstruction, or perforation) caused by gastric cancer

10. Forced expiratory volume in 1 second (FEV1)<50% of predicted values

11. Inclusion in another clinical trial

Related Conditions & MeSH terms

• Stomach Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Department of Gastric Surgery	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival rate	3-year disease free survival rate	36 months
Secondary	3-year overall survival rate	3-year overall survival rate	36 months
Secondary	Morbidity rates	This is for the incidence of early postoperative complications, which defined as the event observed within 30 days after surgery.	30 days
Secondary	Mortality rates	This is for the early mortality, which defined as the event observed within 30 days after surgery.	30 days
Secondary	Total number of retrieved lymph nodes	Total number of retrieved lymph nodes after surgery	One month after surgery
Secondary	Intraoperative morbidity rates	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.	1 day
Secondary	The variation of white blood cell count	The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.	Preoperative 7 days and postoperative 1, 3, and 5 days
Secondary	The variation of hemoglobin	The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.	Preoperative 7 days and postoperative 1, 3, and 5 days
Secondary	The variation of C-reactive protein	The values of C-reactive protein in milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response	Preoperative 7 days and postoperative 1, 3, and 5 days
Secondary	3-year recurrence pattern	Recurrence patterns are classified into four categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, and mixed type	36 months
Secondary	Time to first ambulation	Time to first ambulation in days is used to assess the postoperative recovery course.	30 days
Secondary	Time to first flatus	Time to first flatus in days is used to assess the postoperative recovery course.	30 days
Secondary	Time to first liquid diet	Time to first liquid diet in days is used to assess the postoperative recovery course.	30 days
Secondary	Time to first soft diet	Time to first soft diet in days is used to assess the postoperative recovery course.	30 days
Secondary	Duration of postoperative hospital stay	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.	30 days