Predicting Efficacy of Preoperative Immunotherapy in Advanced Gastric Cancer
11 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Observacional
Inscrição (Estimado)
120
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Runhua Feng
- Número de telefone: 0086-13611920056
- E-mail: frh10960@rjh.com.cn
Locais de estudo
-
-
-
Shanghai, China
- Recrutamento
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
-
Contato:
- Runhua Feng
- Número de telefone: 0086-13611920056
- E-mail: frh10960@rjh.com.cn
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
|
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 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Predictive performance of FAPI and Grazytracer PET/CT
Prazo: 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.
|
an average of 3 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Association of PET Parameters with TRG, 5-year DFS, and OS
Prazo: Through study completion and up to 5 years post-treatment
|
Quantitative PET parameters (SUVmax, SUVpeak, TBR, and others) will be correlated 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
Prazo: Through study completion and up to 5 years post-treatment
|
FAP and Granzyme B expression levels in tumor tissue will be correlated with TRG, 5-year DFS, and OS
|
Through study completion and up to 5 years post-treatment
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
17 de junho de 2025
Conclusão Primária (Estimado)
31 de maio de 2033
Conclusão do estudo (Estimado)
31 de maio de 2033
Datas de inscrição no estudo
Enviado pela primeira vez
11 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de setembro de 2026
Primeira postagem (Real)
17 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de setembro de 2026
Última verificação
1 de março de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 2025 CER 330
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .