Predicting Efficacy of Preoperative Immunotherapy in Advanced Gastric Cancer
2026년 9월 11일 업데이트: Ruijin Hospital
Predicting Efficacy of Preoperative Immunotherapy Combined Treatment in Advanced Gastric Cancer
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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (추정된)
120
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Runhua Feng
- 전화번호: 0086-13611920056
- 이메일: frh10960@rjh.com.cn
연구 장소
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Shanghai, 중국
- 모병
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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연락하다:
- Runhua Feng
- 전화번호: 0086-13611920056
- 이메일: frh10960@rjh.com.cn
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
Outpatients or inpatients who meet the eligibility criteria will be referred by the Department of Gastrointestinal Surgery at our hospital for enrollment in this clinical study.
설명
Inclusion Criteria:
- 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: 0-1.
- 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.
Exclusion Criteria:
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
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A FAP-targeted radiotracer for PET/CT imaging; administered intravenously.
A Granzyme B-targeted radiotracer for PET/CT imaging; administered intravenously.
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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.
|
A FAP-targeted radiotracer for PET/CT imaging; administered intravenously.
A Granzyme B-targeted radiotracer for PET/CT imaging; administered intravenously.
|
|
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.
|
A FAP-targeted radiotracer for PET/CT imaging; administered intravenously.
A Granzyme B-targeted radiotracer for PET/CT imaging; administered intravenously.
|
|
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.
|
A FAP-targeted radiotracer for PET/CT imaging; administered intravenously.
A Granzyme B-targeted radiotracer for PET/CT imaging; administered intravenously.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Predictive performance of FAPI and Grazytracer PET/CT
기간: an average of 3 years
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Predictive performance assessed by AUC, with sensitivity, specificity, PPV, NPV, and accuracy at optimal cutoff, using tumor regression grade (TRG) as the reference standard.
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an average of 3 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Association of PET Parameters with TRG, 5-year DFS, and OS
기간: Through study completion and up to 5 years post-treatment
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Quantitative PET parameters (SUVmax, SUVpeak, TBR, and others) will be correlated with TRG, 5-year DFS, and OS.
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Through study completion and up to 5 years post-treatment
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Association of Tumor Microenvironment Biomarkers (FAP and Granzyme B Expression) with TRG, 5-Year DFS, and OS
기간: Through study completion and up to 5 years post-treatment
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FAP and Granzyme B expression levels in tumor tissue will be correlated with TRG, 5-year DFS, and OS
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Through study completion and up to 5 years post-treatment
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 6월 17일
기본 완료 (추정된)
2033년 5월 31일
연구 완료 (추정된)
2033년 5월 31일
연구 등록 날짜
최초 제출
2026년 9월 11일
QC 기준을 충족하는 최초 제출
2026년 9월 11일
처음 게시됨 (실제)
2026년 9월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 11일
마지막으로 확인됨
2026년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025 CER 330
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아니
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