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Predicting Efficacy of Preoperative Immunotherapy in Advanced Gastric Cancer

11 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

120

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
      • Shanghai, China
        • Werving
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

  1. Age: 18 years ≤ age ≤ 80 years.
  2. The subject must have histopathologically confirmed gastric adenocarcinoma via gastroscopic biopsy.
  3. 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.
  4. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1.
  5. Hematology: white blood cell count > 4 × 10⁹/L, neutrophil count > 2 × 10⁹/L, hemoglobin > 90 g/L, and platelet count > 100 × 10⁹/L.
  6. Cardiac function: left ventricular ejection fraction (LVEF) > 50%.
  7. Liver function: total bilirubin < 1.5 × the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5 × ULN.
  8. Renal function: serum creatinine ≤ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) > 60 mL/min.
  9. The subject must agree to participate in this clinical trial and sign the informed consent form.
  10. The subject must demonstrate good compliance, commit to adhering to the study procedures, and cooperate with the full implementation of the study process.
  11. The subject must have no plans for pregnancy within 6 months.

Exclusion Criteria:

  1. Patients with other primary malignancies within 5 years, with the exception of adequately treated basal cell carcinoma and squamous cell carcinoma of the skin.
  2. Patients with known hypersensitivity or contraindications to chemotherapeutic or immunotherapeutic agents.
  3. 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.
  4. Patients with severe psychiatric disorders, or those who are mentally impaired and unable to cooperate with the required study assessments.
  5. Women who are pregnant, possibly pregnant, or breastfeeding.
  6. Patients with poor compliance.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Diagnostische toets: FAPI PET/CT Imaging
A FAP-targeted radiotracer for PET/CT imaging; administered intravenously.
Diagnostische toets: Grazytracer PET/CT Imaging
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.
Diagnostische toets: FAPI PET/CT Imaging
A FAP-targeted radiotracer for PET/CT imaging; administered intravenously.
Diagnostische toets: Grazytracer PET/CT Imaging
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.
Diagnostische toets: FAPI PET/CT Imaging
A FAP-targeted radiotracer for PET/CT imaging; administered intravenously.
Diagnostische toets: Grazytracer PET/CT Imaging
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.
Diagnostische toets: FAPI PET/CT Imaging
A FAP-targeted radiotracer for PET/CT imaging; administered intravenously.
Diagnostische toets: Grazytracer PET/CT Imaging
A Granzyme B-targeted radiotracer for PET/CT imaging; administered intravenously.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Predictive performance of FAPI and Grazytracer PET/CT
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Association of PET Parameters with TRG, 5-year DFS, and OS
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ruijin Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

17 juni 2025

Primaire voltooiing (Geschat)

31 mei 2033

Studie voltooiing (Geschat)

31 mei 2033

Studieregistratiedata

Eerst ingediend

11 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 september 2026

Eerst geplaatst (Werkelijk)

17 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 september 2026

Laatste update ingediend die voldeed aan QC-criteria

11 september 2026

Laatst geverifieerd

1 maart 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2025 CER 330

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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