IMmune Proteomics to Predict NeoAdjuvant Chemotherapy and ImmunoTherapy Response in Gastric Cancer

NCT ID: NCT06662110

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 206 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2029-06-30

Brief Summary

The overall efficacy of neoadjuvant treatment for advanced gastric cancer is limited due to significant heterogeneity in patient responses. While neoadjuvant therapy offers hope for improved clinical outcomes, the key challenge is accurately predicting individual treatment responses. Identifying reliable biomarkers to guide treatment decisions is therefore critical. Immune factors are pivotal in the efficacy of gastric cancer treatment, but most research has predominantly focused on the tumor immune microenvironment. This study aims to validate the predictive value of systemic immune markers in predicting neoadjuvant treatment responses in advanced gastric cancer.

Building on our previous research, where we established a retrospective cohort of patients with advanced gastric cancer undergoing preoperative chemotherapy, we employed a novel serum proteomics platform based on proximity extension assays (PEA) to measure key immune protein levels in patient serum. This led to the development of the PSRscore system, a serum immune protein score that effectively predicted tumor regression after preoperative chemotherapy (published in Cell Reports Medicine, doi: 10.1016/j.xcrm.2023.100931).

In this prospective cohort study, we will enroll 166 patients with resectable advanced gastric cancer undergoing neoadjuvant chemotherapy. Baseline serum samples will be collected prior to treatment, and the PSRscore will be used to predict tumor regression. Pathological evaluation post-chemotherapy will confirm tumor response, helping to further validate and refine the PSRscore system. Additionally, an exploratory cohort of 40 patients receiving combined neoadjuvant chemotherapy and immunotherapy will be included to evaluate the correlation between PSRscore and clinical benefit from immunotherapy.

This research is expected to lead to the development of a predictive diagnostic kit based on the PSRscore for advanced gastric cancer patients undergoing neoadjuvant therapy, with the ultimate goal of improving clinical decision-making and enhancing treatment outcomes for gastric cancer patients.

Conditions

Gastric Cancer, Gastroesophageal Junction Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

neoadjuvant chemotherapy cohort

Resectable gastric cancer patients who received neoadjuvant chemotherapy, with the SOX regimen as the representative treatment plan, in accordance with standard clinical practice.

PSRscore

Intervention Type: DIAGNOSTIC_TEST

PSRscore calculated based on baseline serum immune proteomics

neoadjuvant chemotherapy plus immunotherapy cohort

Resectable gastric cancer patients who received neoadjuvant chemotherapy plus immunotherapy in accordance with standard clinical practice.

PSRscore

Intervention Type: DIAGNOSTIC_TEST

PSRscore calculated based on baseline serum immune proteomics

Interventions

PSRscore

PSRscore calculated based on baseline serum immune proteomics

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Males or females aged 18 to 75 years;

2. Newly diagnosed histologically confirmed gastric adenocarcinoma;

3. Lesion located in the stomach or gastroesophageal junction as assessed by endoscopic ultrasound and enhanced CT, with clinical staging of T3-4NxM0 (based on the 8th edition of AJCC TNM classification);

4. Determined suitable for neoadjuvant chemotherapy or neoadjuvant chemotherapy combined with immunotherapy after multidisciplinary consultation, with potential for curative resection post-treatment. The chemotherapy regimen is restricted to fluoropyrimidine and platinum-based systemic chemotherapy; the immunotherapy regimen is restricted to immune checkpoint inhibitors.

Exclusion Criteria

1. Prior receipt of any anti-tumor therapy for current gastric cancer or receipt of anti-tumor drugs for other conditions within the past 4 weeks;

2. Presence of another malignancy or multiple primary tumors;

3. Serious comorbidities with a life expectancy of less than 5 years;

4. Severe chronic or active infections requiring systemic anti-infective therapy;

5. Blood transfusion within the past week;

6. Receipt of corticosteroid or immunosuppressive therapy within the past 2 weeks;

7. Administration of a live vaccine within the past 4 weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xuefei Wang

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Zhaoqing Tang

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Yuan Gu

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Zhongshan Hospital, Fudan University

Xuhui District, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xuefei Wang

Role: CONTACT

wang.xuefei@zs-hospital.sh.cn

+ 86 21 64041990

Facility Contacts

Yuan Gu, M.D.

Role: primary

gu.yuan@zs-hospital.sh.cn

86+19533298320

References

Tang Z, Gu Y, Shi Z, Min L, Zhang Z, Zhou P, Luo R, Wang Y, Cui Y, Sun Y, Wang X. Multiplex immune profiling reveals the role of serum immune proteomics in predicting response to preoperative chemotherapy of gastric cancer. Cell Rep Med. 2023 Feb 21;4(2):100931. doi: 10.1016/j.xcrm.2023.100931. Epub 2023 Jan 31.

Reference Type: BACKGROUND

PMID: 36724786 (View on PubMed)

Other Identifiers

IMPACT-GC

Identifier Type: -

Identifier Source: org_study_id