Predicting Efficacy of Preoperative Immunotherapy Combined Treatment in Advanced Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Predictive performance of FAPI and Grazytracer PET/CT
研究概览
简要总结
This study intends to employ FAPI and Grazytracer PET/CT to predict the therapeutic response to preoperative immunotherapy-based combination regimens in patients with advanced gastric cancer. The study is expected to provide an early, non-invasive predictive tool for immunotherapy-based combination therapy in gastric cancer, offer molecular imaging-based evidence for treatment stratification, and facilitate the optimization of precision therapeutic strategies.
详细描述
This prospective study intends to employ FAPI and Grazytracer PET/CT to predict the therapeutic response to preoperative immunotherapy-based combination regimens (neoadjuvant therapy or conversion therapy) in patients with advanced gastric cancer. Enrolled patients will undergo paired FAPI PET/CT and Grazytracer PET/CT examinations at baseline and at a predefined follow-up time point (either after one cycle or at treatment completion). With the tumor regression grade (TRG) serving as the reference standard, the study will investigate the correlation between PET/CT-derived parameters and therapeutic response, as well as the predictive performance of these parameters for prognosis. This study is expected to provide an early, non-invasive predictive tool for preoperative immunotherapy-based combination therapy in advanced gastric cancer, thereby avoiding ineffective treatment and the associated healthcare costs and patient burden; moreover, it is anticipated to offer molecular imaging-based evidence for treatment stratification in gastric cancer immunotherapy, ultimately facilitating the optimization of precision therapeutic strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years ≤ age ≤ 80 years.
- •The subject must have histopathologically confirmed gastric adenocarcinoma via gastroscopic biopsy.
- •Clinical stage: cT3-4aN0-3M0 (according to the 8th edition UICC gastric cancer cTNM) with surgically resectable locally advanced gastric cancer, or cT3-4bN1-3M1 (non-peritoneal metastasis) with advanced gastric cancer.
- •Eastern Cooperative Oncology Group (ECOG) performance status score: 0-
- •Hematology: white blood cell count > 4 × 10⁹/L, neutrophil count > 2 × 10⁹/L, hemoglobin > 90 g/L, and platelet count > 100 × 10⁹/L.
- •Cardiac function: left ventricular ejection fraction (LVEF) > 50%.
- •Liver function: total bilirubin < 1.5 × the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5 × ULN.
- •Renal function: serum creatinine ≤ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) > 60 mL/min.
- •The subject must agree to participate in this clinical trial and sign the informed consent form.
- •The subject must demonstrate good compliance, commit to adhering to the study procedures, and cooperate with the full implementation of the study process.
- •The subject must have no plans for pregnancy within 6 months.
排除标准
- •Patients with other primary malignancies within 5 years, with the exception of adequately treated basal cell carcinoma and squamous cell carcinoma of the skin.
- •Patients with known hypersensitivity or contraindications to chemotherapeutic or immunotherapeutic agents.
- •Patients with severe concomitant diseases that, in the investigator's judgment, render the patient unsuitable for enrollment in this clinical study, including but not limited to severe cardiopulmonary insufficiency, severe bone marrow suppression, and severe hepatic or renal dysfunction.
- •Patients with severe psychiatric disorders, or those who are mentally impaired and unable to cooperate with the required study assessments.
- •Women who are pregnant, possibly pregnant, or breastfeeding.
- •Patients with poor compliance.
研究组 & 干预措施
Early Efficacy Evaluation Group for Neoadjuvant Immunotherapy-Based Combination Therapy
Patients receiving neoadjuvant immunotherapy-based combination therapy - paired FAPI and Grazytracer PET/CT at baseline and after 1 cycle.
干预措施: FAPI PET/CT Imaging (Diagnostic Test)
Early Efficacy Evaluation Group for Neoadjuvant Immunotherapy-Based Combination Therapy
Patients receiving neoadjuvant immunotherapy-based combination therapy - paired FAPI and Grazytracer PET/CT at baseline and after 1 cycle.
干预措施: Grazytracer PET/CT Imaging (Diagnostic Test)
Efficacy Evaluation Group for Neoadjuvant Immunotherapy-Based Combination Therapy
Patients receiving neoadjuvant immunotherapy-based combination therapy - paired FAPI and Grazytracer PET/CT at baseline and at treatment completion.
干预措施: FAPI PET/CT Imaging (Diagnostic Test)
Efficacy Evaluation Group for Neoadjuvant Immunotherapy-Based Combination Therapy
Patients receiving neoadjuvant immunotherapy-based combination therapy - paired FAPI and Grazytracer PET/CT at baseline and at treatment completion.
干预措施: Grazytracer PET/CT Imaging (Diagnostic Test)
Early Efficacy Evaluation Group for Conversion Immunotherapy-Based Combination Therapy
Patients receiving conversion immunotherapy-based combination therapy - paired FAPI and Grazytracer PET/CT at baseline and after 1 cycle.
干预措施: FAPI PET/CT Imaging (Diagnostic Test)
Early Efficacy Evaluation Group for Conversion Immunotherapy-Based Combination Therapy
Patients receiving conversion immunotherapy-based combination therapy - paired FAPI and Grazytracer PET/CT at baseline and after 1 cycle.
干预措施: Grazytracer PET/CT Imaging (Diagnostic Test)
Efficacy Evaluation Group for Conversion Immunotherapy-Based Combination Therapy
Patients receiving conversion immunotherapy-based combination therapy - paired FAPI and Grazytracer PET/CT at baseline and at treatment completion.
干预措施: FAPI PET/CT Imaging (Diagnostic Test)
Efficacy Evaluation Group for Conversion Immunotherapy-Based Combination Therapy
Patients receiving conversion immunotherapy-based combination therapy - paired FAPI and Grazytracer PET/CT at baseline and at treatment completion.
干预措施: Grazytracer PET/CT Imaging (Diagnostic Test)
结局指标
主要结局
Predictive performance of FAPI and Grazytracer PET/CT
时间窗: an average of 3 years
Predictive performance assessed by AUC, with sensitivity, specificity, PPV, NPV, and accuracy at optimal cutoff, using tumor regression grade (TRG) as the reference standard.
次要结局
- Association of PET Parameters with TRG, 5-year DFS, and OS(Through study completion and up to 5 years post-treatment)
- Association of Tumor Microenvironment Biomarkers (FAP and Granzyme B Expression) with TRG, 5-Year DFS, and OS(Through study completion and up to 5 years post-treatment)