Establishment of Serum Proteomics Subtypes of Gastric Cancer and Its Clinical Application - Trial NCT06335576
Access comprehensive clinical trial information for NCT06335576 through Pure Global AI's free database. This phase not specified trial is sponsored by Shanghai Zhongshan Hospital and is currently Not yet recruiting. The study focuses on Gastric Cancer. Target enrollment is 89 participants.
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Study Focus
This study is a single-arm and observational study with no intervention.
Observational
other
Sponsor & Location
Shanghai Zhongshan Hospital
Timeline & Enrollment
N/A
Mar 31, 2024
Dec 31, 2026
Primary Outcome
C-index
Summary
This study is a prospective, single-center, observational study aimed at detecting the status
 of serum protein profiles at key time points in gastric cancer patients receiving neoadjuvant
 therapy for advanced disease, and constructing a serum protein model for evaluating the
 efficacy of neoadjuvant therapy for gastric cancer. Subjects will receive neoadjuvant therapy
 (treatment regimen determined by the primary physician, limited to systemic therapy, with
 options including immune checkpoint inhibitor-based regimens and non-immune checkpoint
 inhibitor-based regimens). After four cycles of treatment, the efficacy will be assessed.
 Patients eligible for R0 resection will undergo D2 radical surgery regardless of tumor
 regression, while those ineligible for R0 resection will enter the palliative treatment phase
 (Note: Subjects are all patients who require neoadjuvant therapy even if they do not
 participate in this clinical study). Patients will receive regular follow-up evaluations for
 metastasis/recurrence and survival until tumor recurrence/progression or the last known date
 of patient survival (Note: Regular follow-up in this study follows the frequency of routine
 clinical follow-ups). The primary endpoint is progression-free survival (PFS), and the
 secondary endpoint is pathological response rate (based on Becker tumor regression grading,
 with residual tumor less than 50% considered effective preoperative treatment).
 
 Peripheral venous blood samples will be collected before the start of neoadjuvant therapy
 (blood sampling point 1 - baseline) and before surgery after neoadjuvant therapy (blood
 sampling point 2 - post-treatment). Approximately 3 ml of blood will be collected each time,
 and about 1.5 ml of serum will be obtained after processing. Serum protein profiling will be
 conducted to assess the expression of protein profiles at these treatment time points.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06335576
Non-Device Trial