Predicting Efficacy of Preoperative Immunotherapy in Advanced Gastric Cancer
11 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Stimato)
120
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Runhua Feng
- Numero di telefono: 0086-13611920056
- Email: frh10960@rjh.com.cn
Luoghi di studio
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Shanghai, Cina
- Reclutamento
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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Contatto:
- Runhua Feng
- Numero di telefono: 0086-13611920056
- Email: frh10960@rjh.com.cn
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Predictive performance of FAPI and Grazytracer PET/CT
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Association of PET Parameters with TRG, 5-year DFS, and OS
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
17 giugno 2025
Completamento primario (Stimato)
31 maggio 2033
Completamento dello studio (Stimato)
31 maggio 2033
Date di iscrizione allo studio
Primo inviato
11 settembre 2026
Primo inviato che soddisfa i criteri di controllo qualità
11 settembre 2026
Primo Inserito (Effettivo)
17 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 settembre 2026
Ultimo verificato
1 marzo 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 2025 CER 330
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .