Evaluating a zebrafish model for predicting chemotherapy effects in gastric cancer

Consistency Evaluation of a Patient-derived Tumor Xenograft Zebrafish Model in Predicting Anti-cancer Efficacy of Conventional Drugs for Gastric Cancer

This study is testing if a zebrafish model can help predict how well chemotherapy works for people with advanced gastric cancer.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05616533 on ClinicalTrials.gov

What this trial studies

This study aims to compare the tumor response in gastric cancer patients undergoing neoadjuvant chemotherapy with the results from a zebrafish patient-derived tumor xenograft (PDX) model receiving the same treatment. By transplanting tumor samples from patients into zebrafish and administering the same chemotherapy regimen, researchers will analyze and compare the tumor responses from both the clinical setting and the zebrafish model. The goal is to determine if the zebrafish PDX model can accurately predict the effectiveness of chemotherapy in advanced gastric cancer patients. This could lead to better treatment planning and improved patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with advanced gastric cancer who are scheduled to receive neoadjuvant chemotherapy.

Not a fit: Patients with inoperable advanced gastric cancer or those with metastatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the ability to predict chemotherapy effectiveness, leading to more personalized and effective treatment strategies for gastric cancer patients.

How similar studies have performed: While the use of zebrafish models for drug sensitivity prediction is promising, this specific approach has not been widely tested in the context of gastric cancer, making it a novel investigation.

Eligibility criteria

Inclusion Criteria:

1. patients aged 18-75years,
2. patients with gastric cancer confirmed by histology or cytology at first visit,
3. patients with advanced tumor by imaging evaluation,
4. patients with preoperative neoadjuvant therapy;
5. Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1;
6. tolerance to chemotherapy in laboratory examination;
7. hematology examination: no obvious signs of hematological diseases, ANC ≥1.5 × 109/L before enrollment; Platelet count ≥80 × 109/L, HB ≥90 g/L, WBC ≥3.0 × 109/L, and no bleeding tendency;
8. biochemical examination: Total Bilirubin \<1.5 times of upper limit of normal value, AST, ALT \< 2.5 times of upper limit of normal value, creatinine \< 1.5 times of upper limit of normal value;

Exclusion Criteria:

1. patients with inoperable advanced gastric cancer,
2. patients with metastatic or primary gastric cancer,
3. pregnant or lactating women,
4. patients with a history of other malignancies in the last 5 years;
5. for those with a history of uncontrolled epilepsy, central nervous system disease or mental disorders, the severity of the clinical condition was assessed by the investigator as impeding the signing of informed consent or affecting the patient's compliance with oral medication;
6. clinically serious (i.e. active) heart disease, such as symptomatic coronary heart disease, NYHA Class II or more heart failure, or arrhythmias requiring medical intervention; Or a history of myocardial infarction within the last 12 months;
7. severe diabetes-related complications, such as diabetic nephropathy, diabetic ketosis, etc.
8. gastrointestinal obstruction or abnormal physiological function, or malabsorption syndrome, which may affect drug absorption;
9. gastrointestinal bleeding in the last two weeks or at high risk of bleeding as judged by the investigator;
10. patients with known peripheral nerve disease ≥ NCI-CTC AE Grade 1, but only with deep tendon reflexes (DTR) ;
11. organ transplantation requires immunosuppressive therapy;
12. the presence of any active, known or suspected autoimmune disease.
13. uncontrolled severe infection or other severe concomitant disease
14. hypersensitivity to paclitaxel, Oxaliplatin, 5-FU, or any clinically useful anti-gastric cancer agent.

Where this trial is running

Hangzhou, Zhejiang

• gastrointestinal department of second affiliated hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Xiaoli Jin, Dr — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Xiaoli Jin, Dr

Conditions Precise Prediction of Therapy Efficiency; gastric cancer; zebrafish; patient-derived tumor xenograft model; prediction; therapy efficiency