Clinical trial · Observational
Evaluation of Consistency of PDX Model for Predicting Therapeutic Effect of Gastric Cancer
Consistency Evaluation of a Patient-derived Tumor Xenograft Zebrafish Model in Predicting Anti-cancer Efficacy of Conventional Drugs for Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this study is to compare the tumor response in gastric cancer patients given neoadjuvant chemotherapy with the corresponding result obtained from zebrafish patient-derived tumor xenograft(PDX) model given the same regimen. The main question it aims to answer is whether this PDX model of zebrafish could accurately predict the effect of chemotherapy in advanced gastric cancer. Participants will be given the standard neoadjuvant treatment administrated by their own doctors and tumor response will be observed and recorded. Meanwhile, tumor samples derived from patients before chemotherapy will be transplanted to zebrafish and the same regimen will be given to the PDX models correspondingly. The tumor response data both from clinical practice and PDX model platform will be analysed and compared to evaluate the power of this zebrafish model platform in drug efficiency prediction.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Precise Prediction of Therapy Efficiency | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy of tumor before treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- focused group
- description
- Advanced gastric patients that will be treated with neoadjuvant therapy are enrolled. Every clinical decision such as regimen or dosage will be decided by their own doctors without any interventions. Tumor samples will be obtained before the first cycle of the treatment and will be transplanted to the zebrafish model. Compared results will be analyzed in future.
- interventionNames
- Other: biopsy of tumor before treatment
Primary outcomes (1)
- measure
- The coincidence rate of tumor response obtained from 50 PDX models with clinical real tumor response acquired from corresponding patients received neoadjuvant therapy.
- timeFrame
- about 3 months (from the first cycle of neoadjuvant therapy to the surgery)
- description
- Drugs used in the zebrafish PDX model are as same as those administrated in the clinical practice with the corresponding patient. Immunofluorescence quantitative detection would be used to evaluate the tumor response in PDX model while RECIST 1.1 and Becker criterion would be applied to evaluate the real tumor response in clinical practice.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
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