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NCT Number: NCT05140746

Prediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer

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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Runhua Feng

CONTACT

[email protected]

0086-13611920056

Zhenggang Zhu

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT

Diagnostic Test

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.

Primary outcomes

  1. Prediction for NAC efficacy

    Time frame: Two weeks after surgery

    Predictive value of 68Ga-FAPI PET/CT and 18F-FDG PET/CT for LAGC in NAC response assessment.

  2. Standardized uptake value(SUV)

    Time frame: Two weeks after surgery

    SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for primary gastric cancer.

  3. Target-to-background ratio(TBR)

    Time frame: Two weeks after surgery

    68Ga-FAPI and 18F-FDG uptake ratio of primary gastric cancer to mediastinum blood pool on PET/CT images.

Secondary outcomes

  1. Diagnostic efficacy for metastatic lymph nodes

    Time frame: Two weeks after surgery

    The sensitivity, specificity, NPV, PPV and accuracy of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with those of 18F-FDG PET/CT.

  2. Disease free survival

    Time frame: 5 years

    Disease free survival

  3. Overall survival

    Time frame: 5 years

    Overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2027
First posted
Dec 1, 2021
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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