Prediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer

Официальное название

A Prospective Study on Predicting the Efficacy of Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer.

Обзор

This study intends to explore the value of 68Ga-FAPI-04 and 18F-FDG PET/CT in the evaluation of treatment response to neoadjuvant chemotherapy(NAC) for patients with locally advanced gastric cancer(LAGC).

Подробное описание

Before the start of NAC, baseline 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT scans will be scheduled in all enrolled patients. Next, the patients with resectable LAGC will receive NAC treatment, surgery will follow 3\~6 weeks after finishing NAC. Abdomen 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scheduled after one cycle of NAC treatment or before surgery. Imaging response measurements will be compared with the histopathological tumor regression grade (TRG) of the resection specimen as gold standard.

Вмешательства

• Диагностический тест 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
  Baseline 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT scans before NAC followed by abdomen 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT scans after one cycle of NAC treatment or before surgery.

Первичные конечные точки

• Prediction for NAC efficacy [Срок оценки: Two weeks after surgery]
• Standardized uptake value(SUV) [Срок оценки: Two weeks after surgery]
• Target-to-background ratio(TBR) [Срок оценки: Two weeks after surgery]

Вторичные конечные точки (3)

• Diagnostic efficacy for metastatic lymph nodes [Срок оценки: Two weeks after surgery]
• Disease free survival [Срок оценки: 5 years]
• Overall survival [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Age between 18-75 years.
• Histologically confirmed gastric adenocarcinoma through gastroscopy.
• Resectable gastric cancer.
• ECOG performance status 0-1.
• White blood count >4x109/L, Absolute neutrophil count (ANC) >2x109/L, Hemoglobin (Hb)>90g/L, Platelets >100x109/L.
• Ejection Fraction>50%.
• Serum bilirubin <1.5x ULN; ALT and AST <1.5x ULN.
• Serum creatinine ≤1.5x ULN, or GFR> 60ml/min.
• Agreement to participate in this study with informed consent form.
• Willingness and ability to comply with the protocol for the duration of the study.
• No children bearing petential in the next six months before enrollment.

Критерии исключения

• With second primary malignant diseases in past five years, exceptions include basal cell and squamous cell carcinoma of the skin that have been cured.
• Known hypersensitivity reaction to chemotherapy drugs or with contraindications.
• With severe disease or other unsuitable conditions determined by investigators. Inadequate organ function.
• With uncontrollable diabetic or fasting blood glucose level ≥11 mmol/L on the test-day.
• With severe mental symptoms, unconscious or unable to complete the examination.
• Pregnancy or possibly pregnant woman, breastfeeding woman.
• Lack of compliance.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Shanghai Ruijin Hospital — Шанхай

Публикации

• Miao Y, Feng R, Yu T, Guo R, Zhang M, Wang Y, Hai W, Shangguan C, Zhu Z, Li B. Value of 68Ga-FAPI-04 and 18F-FDG PET/CT in Early Prediction of Pathologic Response to Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer. J Nucl Med. 2024 Feb 1;65(2):213-220. doi: 10.2967/jnumed.123.266403. PMID 38164574

Идентификаторы

NCT: NCT05140746 · PET-NAC-GC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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