NCT06662110Recruiting
IMmune Proteomics to Predict neoAdjuvant Chemotherapy and immunoTherapy Response in Gastric Cancer
A Prospective Cohort Study on Serum Immune Protein Signature for Predicting Neoadjuvant Therapy Efficacy in Advanced Gastric Cancer
Source: ClinicalTrials.gov · Last updated 28 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 206 (estimated)
- First submitted
- 21 Oct 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06662110
What you commit to
- Study type: Observational
- Planned participants: 206
- From 1 Aug 2024 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Receipt of corticosteroid or immunosuppressive therapy within the past 2 weeks;
- Administration of a live vaccine within the past 4 weeks.
Other illness
- Presence of another malignancy or multiple primary tumors;
- Severe chronic or active infections requiring systemic anti-infective therapy;
Other
- Serious comorbidities with a life expectancy of less than 5 years;
- Blood transfusion within the past week;
Who the study is looking for
- Males or females aged 18 to 75 years;
- Newly diagnosed histologically confirmed gastric adenocarcinoma;
- 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);
- 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.
Age in the registry: 18 years to 75 years · Sex: All
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital, Fudan University Coordinator of this site? Confirm its status | Xuhui District | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.