Prediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer
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ClinicalTrials.gov Identifier: NCT05140746 |
Recruitment Status :
Recruiting
First Posted : December 1, 2021
Last Update Posted : December 1, 2021
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Condition or disease | Intervention/treatment | Phase |
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Gastric Cancer | Diagnostic Test: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Prospective Study on Predicting the Efficacy of Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer. |
Actual Study Start Date : | September 10, 2020 |
Estimated Primary Completion Date : | September 10, 2022 |
Estimated Study Completion Date : | September 10, 2027 |

Arm | Intervention/treatment |
---|---|
Experimental: PET/CT for prediction of NAC efficacy
68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scanned before, during or after NAC.
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Diagnostic Test: 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. |
- 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.
- 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.
- 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.
- 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.
- Disease free survival [ Time Frame: 5 years ]Disease free survival
- Overall survival [ Time Frame: 5 years ]Overall survival

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05140746
Contact: Ying Miao | 0086-13671921521 | myada821@hotmail.com |
China, Shanghai | |
Shanghai Ruijin Hospital | Recruiting |
Shanghai, Shanghai, China, 200025 | |
Contact: Runhua Feng 0086-13611920056 frh10960@rjh.com.cn | |
Principal Investigator: Zhenggang Zhu |
Principal Investigator: | Zhenggang Zhu | Ruijin Hospital |
Responsible Party: | Ruijin Hospital |
ClinicalTrials.gov Identifier: | NCT05140746 |
Other Study ID Numbers: |
PET-NAC-GC |
First Posted: | December 1, 2021 Key Record Dates |
Last Update Posted: | December 1, 2021 |
Last Verified: | November 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Stomach Diseases Fluorodeoxyglucose F18 Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |