A Systems Approach to Immunotherapy Biomarker Identification Within the Postoperative Wound-Healing Microenvironment in Patients With Gastroesophageal Cancer

GastroEsophageal Cancer Clinical Trial

— BAISIC  

Official title:

A Systems Approach to Immunotherapy Biomarker Identification Within the Postoperative Wound-Healing Microenvironment in Patients With Gastroesophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05338060
• Other study ID #: U21-05-4450
• Status: Recruiting
• Start date: January 26, 2022
• Est. completion date: January 30, 2025

Study information

• Verified date: February 2024
• Source: Inova Health Care Services
• Contact: Keary Janet, BS
• Phone: 571-472-0224
• Email: keary.janet[@]inova.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research is to collect surgical drain fluid and blood from patients who have undergone surgery for gastric or esophageal cancer, and to analyze the fluid and blood using a variety of laboratory techniques for molecular markers capable of predicting response to immunotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing esophagectomy or gastrectomy for gastroesophageal cancer.

• Adult males and females at least 18 years of age

• Ability to complete testing in the protocol and attend study visits

• Able and willing to consent to protocol

• Adequate organ function Absolute Neutrophil Count (ANC) =1.5 x 103/µL Platelets =100 x 103/µL Hemoglobin >9.0 g/dL Total Bilirubin (</= 2.0 mg/dl at time of Y90 radioembolization) AST/ALT =5 x upper limit of normal Albumin >3 g/dL Creatinine =1.5 mg/dL

Exclusion Criteria:

• Female patients who are pregnant or breast-feeding

• Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.

• Life-threatening intercurrent illness

• Anticipated poor compliance

• Prisoners or subjects who are involuntarily incarcerated

• Persons with decisional incapacity/cognitive impairment

• Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator unsuitable for the study

• Subject is enrolled in a separate interventional clinical trial

Related Conditions & MeSH terms

• GastroEsophageal Cancer

Intervention

Other:
• prospective collection of surgical exudates (SEs)
prospective collection of surgical exudates (SEs) from patients who are hospitalized for post-operative recovery from esophagectomy or gastrectomy for gastroesophageal cancer

Locations

Country	Name	City	State
United States	Inova Schar Cancer Institute	Fairfax	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Inova Health Care Services	George Mason University

Country where clinical trial is conducted

United States, 

References & Publications (25)

Aebersold R, Mann M. Mass spectrometry-based proteomics. Nature. 2003 Mar 13;422(6928):198-207. doi: 10.1038/nature01511. — View Citation

Baldelli E, Calvert V, Hodge A, VanMeter A, Petricoin EF 3rd, Pierobon M. Reverse Phase Protein Microarrays. Methods Mol Biol. 2017;1606:149-169. doi: 10.1007/978-1-4939-6990-6_11. — View Citation

Dholaria B, Hammond W, Shreders A, Lou Y. Emerging therapeutic agents for lung cancer. J Hematol Oncol. 2016 Dec 9;9(1):138. doi: 10.1186/s13045-016-0365-z. — View Citation

Diggs LP, Hsueh EC. Utility of PD-L1 immunohistochemistry assays for predicting PD-1/PD-L1 inhibitor response. Biomark Res. 2017 Mar 15;5:12. doi: 10.1186/s40364-017-0093-8. eCollection 2017. — View Citation

Fredolini C, Meani F, Luchini A, Zhou W, Russo P, Ross M, Patanarut A, Tamburro D, Gambara G, Ornstein D, Odicino F, Ragnoli M, Ravaggi A, Novelli F, Collura D, D'Urso L, Muto G, Belluco C, Pecorelli S, Liotta L, Petricoin EF 3rd. Investigation of the ovarian and prostate cancer peptidome for candidate early detection markers using a novel nanoparticle biomarker capture technology. AAPS J. 2010 Dec;12(4):504-18. doi: 10.1208/s12248-010-9211-3. Epub 2010 Jun 12. — View Citation

Fuse N, Nagahisa-Oku E, Doi T, Sasaki T, Nomura S, Kojima T, Yano T, Tahara M, Yoshino T, Ohtsu A. Effect of RECIST revision on classification of target lesions and overall response in advanced gastric cancer patients. Gastric Cancer. 2013 Jul;16(3):324-8. doi: 10.1007/s10120-012-0187-9. Epub 2012 Aug 22. — View Citation

Gerszten RE, Accurso F, Bernard GR, Caprioli RM, Klee EW, Klee GG, Kullo I, Laguna TA, Roth FP, Sabatine M, Srinivas P, Wang TJ, Ware LB. Challenges in translating plasma proteomics from bench to bedside: update from the NHLBI Clinical Proteomics Programs. Am J Physiol Lung Cell Mol Physiol. 2008 Jul;295(1):L16-22. doi: 10.1152/ajplung.00044.2008. Epub 2008 May 2. — View Citation

Grigg C, Rizvi NA. PD-L1 biomarker testing for non-small cell lung cancer: truth or fiction? J Immunother Cancer. 2016 Aug 16;4:48. doi: 10.1186/s40425-016-0153-x. eCollection 2016. — View Citation

Kato K, Cho BC, Takahashi M, Okada M, Lin CY, Chin K, Kadowaki S, Ahn MJ, Hamamoto Y, Doki Y, Yen CC, Kubota Y, Kim SB, Hsu CH, Holtved E, Xynos I, Kodani M, Kitagawa Y. Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell car — View Citation

Kato K, Sun JM, Shah MA, Enzinger PC, Adenis A, Doi T, et al. LBA8_PR Pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase 3 KEYNOTE-590 study. Annals of Oncology. 2020;31:S1192-S

Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lievre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, — View Citation

Kojima T, Shah MA, Muro K, Francois E, Adenis A, Hsu CH, Doi T, Moriwaki T, Kim SB, Lee SH, Bennouna J, Kato K, Shen L, Enzinger P, Qin SK, Ferreira P, Chen J, Girotto G, de la Fouchardiere C, Senellart H, Al-Rajabi R, Lordick F, Wang R, Suryawanshi S, Bh — View Citation

Luchini A, Fredolini C, Espina BH, Meani F, Reeder A, Rucker S, Petricoin EF 3rd, Liotta LA. Nanoparticle technology: addressing the fundamental roadblocks to protein biomarker discovery. Curr Mol Med. 2010 Mar;10(2):133-41. doi: 10.2174/156652410790963268. — View Citation

Maleki Vareki S, Garrigos C, Duran I. Biomarkers of response to PD-1/PD-L1 inhibition. Crit Rev Oncol Hematol. 2017 Aug;116:116-124. doi: 10.1016/j.critrevonc.2017.06.001. Epub 2017 Jun 9. — View Citation

Moehler M, Shitara K, Garrido M, Salman P, Shen L, Wyrwicz L, et al. LBA6_PR Nivolumab (nivo) plus chemotherapy (chemo) versus chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC)/esophageal adenocarcin

Park CH, Lee JG, Lee AR, Eun CS, Han DS. Network construction of gastric microbiome and organization of microbial modules associated with gastric carcinogenesis. Sci Rep. 2019 Aug 27;9(1):12444. doi: 10.1038/s41598-019-48925-4. — View Citation

Pierobon M, Wulfkuhle J, Liotta L, Petricoin E. Application of molecular technologies for phosphoproteomic analysis of clinical samples. Oncogene. 2015 Feb 12;34(7):805-14. doi: 10.1038/onc.2014.16. Epub 2014 Mar 10. — View Citation

Pin E, Sjoberg R, Andersson E, Hellstrom C, Olofsson J, Jernbom Falk A, Bergstrom S, Remnestal J, Just D, Nilsson P, Manberg A. Array-Based Profiling of Proteins and Autoantibody Repertoires in CSF. Methods Mol Biol. 2019;2044:303-318. doi: 10.1007/978-1-4939-9706-0_19. — View Citation

Popper U, Rumpold H. Update ESMO: gastric and esophageal cancer. memo - Magazine of European Medical Oncology. 2021;14:180-3.

Poste G. Bring on the biomarkers. Nature. 2011 Jan 13;469(7329):156-7. doi: 10.1038/469156a. No abstract available. — View Citation

Prakash A, Rezai T, Krastins B, Sarracino D, Athanas M, Russo P, Zhang H, Tian Y, Li Y, Kulasingam V, Drabovich A, Smith CR, Batruch I, Oran PE, Fredolini C, Luchini A, Liotta L, Petricoin E, Diamandis EP, Chan DW, Nelson R, Lopez MF. Interlaboratory reproducibility of selective reaction monitoring assays using multiple upfront analyte enrichment strategies. J Proteome Res. 2012 Aug 3;11(8):3986-95. doi: 10.1021/pr300014s. Epub 2012 Jul 3. — View Citation

Schwartz LH, Colville JA, Ginsberg MS, Wang L, Mazumdar M, Kalaigian J, Hricak H, Ilson D, Schwartz GK. Measuring tumor response and shape change on CT: esophageal cancer as a paradigm. Ann Oncol. 2006 Jun;17(6):1018-23. doi: 10.1093/annonc/mdl058. Epub 2006 Apr 26. — View Citation

Shitara K, Ozguroglu M, Bang YJ, Di Bartolomeo M, Mandala M, Ryu MH, Fornaro L, Olesinski T, Caglevic C, Chung HC, Muro K, Goekkurt E, Mansoor W, McDermott RS, Shacham-Shmueli E, Chen X, Mayo C, Kang SP, Ohtsu A, Fuchs CS; KEYNOTE-061 investigators. Pembr — View Citation

Sundaram GM, Quah S, Sampath P. Cancer: the dark side of wound healing. FEBS J. 2018 Dec;285(24):4516-4534. doi: 10.1111/febs.14586. Epub 2018 Jun 25. — View Citation

Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of a workflow for collection of SEs from esophageal and gastric cancer patients.	to establish a workflow for collection of SEs from patients affected by esophageal and gastric cancer undergoing surgical resection.	6 months
Secondary	Assay characterization of SEs for Predictive and Prognostic Biomarkers to early vs. late/non-recurrence of malignancy.	SEs will be collected and characterized using different assays with the goal of generating hypotheses of potential predictive and prognostic biomarkers to early (<6 months) vs. late/non-recurrence of malignancy.	24 months