Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06662110

Recruiting

IMPACT-GC: IMmune Proteomics to Predict NeoAdjuvant Chemotherapy and ImmunoTherapy Response in Gastric Cancer

Observational

Phase not listed

Zhongshan Hospital, Fudan University

Sponsor: Shanghai Zhongshan Hospital

Last Updated: October 28, 2024
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

Treatment Category

Diagnostic Test

Required Mutations

None

Trial Started

August 1, 2024

Last Updated by Sponsor

October 28, 2024

Estimated Completion

June 30, 2026

Contact Study

Name:Xuefei Wang

Email:wang.xuefei@zs-hospital.sh.cn

Phone:+ 86 21 64041990

Eligibility

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.

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Design Details

AllocationN/A

Intervention ModelN/A

MaskingN/A

Number to Enroll206

Arms & Interventions

Arms

Interventions

Type: N/A

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

Interventions:

PSRscore

Outcome Measures

Primary Outcome Measures

the sensitivity and specificity of PSRscore in predicting tumor regression after neoadjuvant therapy in patients with advanced gastric cancerFrom enrollment to the end of the pathological examination of all resected tumor samples, an average of 2 years

Secondary Outcome Measures

the sensitivity and specificity of PSRscore in predicting objective response after neoadjuvant treatment in patients with advanced gastric cancerFrom enrollment to the end of all the neo-adjuvant treatment, an average of 2 years

the sensitivity and specificity of PSRscore in predicting progression-free survival (PFS) after neoadjuvant treatment in patients with advanced gastric cancerthough study completion, an average of 5 years

the sensitivity and specificity of PSRscore in predicting overall survival (OS) after neoadjuvant treatment in patients with advanced gastric cancerthough study completion, an average of 5 years

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Trial Sites

This study has 1 trial site

Zhongshan Hospital, Fudan University

Xuhui District, Shanghai, CN

Name:Yuan Gu, M.D.

Recruiting

Xuhui District, Shanghai, 200032 CN

Zhongshan Hospital, Fudan University

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