Evaluating chemotherapy response in advanced gastric cancer
A Prospective Study on Predicting the Efficacy of Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer.
This study is testing if special imaging scans can help predict how well chemotherapy works for people with advanced stomach cancer before they have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05140746 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of 68Ga-FAPI-04 and 18F-FDG PET/CT imaging in predicting the response to neoadjuvant chemotherapy in patients with locally advanced gastric cancer. Patients will undergo baseline PET/CT scans before starting chemotherapy, followed by treatment and subsequent imaging after one cycle or before surgery. The imaging results will be compared to the histopathological tumor regression grade from surgical specimens to determine the accuracy of these imaging techniques in evaluating treatment response.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with histologically confirmed resectable gastric adenocarcinoma and a good performance status.
Not a fit: Patients with second primary malignancies, severe comorbid conditions, or known hypersensitivity to chemotherapy drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate predictions of chemotherapy efficacy, allowing for personalized treatment plans for patients with gastric cancer.
How similar studies have performed: While the use of PET/CT imaging in cancer treatment evaluation is established, this specific approach in gastric cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Age between 18-75 years. 2. Histologically confirmed gastric adenocarcinoma through gastroscopy. 3. Resectable gastric cancer. 4. ECOG performance status 0-1. 5. White blood count \>4x109/L, Absolute neutrophil count (ANC) \>2x109/L, Hemoglobin (Hb)\>90g/L, Platelets \>100x109/L. 6. Ejection Fraction\>50%. 7. Serum bilirubin \<1.5x ULN; ALT and AST \<1.5x ULN. 8. Serum creatinine ≤1.5x ULN, or GFR\> 60ml/min. 9. Agreement to participate in this study with informed consent form. 10. Willingness and ability to comply with the protocol for the duration of the study. 11. No children bearing petential in the next six months before enrollment. Exclusion criteria 1. With second primary malignant diseases in past five years, exceptions include basal cell and squamous cell carcinoma of the skin that have been cured. 2. Known hypersensitivity reaction to chemotherapy drugs or with contraindications. 3. With severe disease or other unsuitable conditions determined by investigators. Inadequate organ function. 4. With uncontrollable diabetic or fasting blood glucose level ≥11 mmol/L on the test-day. 5. With severe mental symptoms, unconscious or unable to complete the examination. 6. Pregnancy or possibly pregnant woman, breastfeeding woman. 7. Lack of compliance.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Ruijin Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zhenggang Zhu — Ruijin Hospital
- Study coordinator: Ying Miao
- Email: myada821@hotmail.com
- Phone: 0086-13671921521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.