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| Name | Class |
|---|---|
| Hangzhou Hunter Biotechnology Incorporation | UNKNOWN |
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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.
The prognosis of advanced gastric cancer treated with surgery only remains quite disappointed. Adjuvant and neoadjuvant chemotherapy had been greatly raising the survive of advanced gastric cancer. However, how to acquired the tumor sensitivity to the following chemotherapy before the treatment, in order to admit reasonable drugs, avoid unexpected progression of tumor and unnecessary loss of surgical opportunity, remained the focus in this field. Zebrafish CDX/PDX model provides a reliable potential platform for drug sensitivity prediction, but the drug sensitivity result concluded by this platform could not fully represent its actual clinic efficacy in human body. Consistency of therapeutic efficacy could be concluded only by comparing the results both in the human body and the model that was given the same regimens. This is the golden standard to evaluate whether the PDX model of zebrafish could accurately predict the effect of chemotherapy, as well as the primary foundation of the clinical practice with this zebrafish model platform for drug efficiency prediction. Therefore, we intend to carry out this clinical study in gastric cancer patients whom were given neoadjuvant chemotherapy. Enrolled individuals was given a biopsy through endoscopy to obtain samples that would be transplanted to the zebrafish model. Same drugs would be give both for the patient and corresponding zebrafish model, and results would be observed carefully to assess the consistency between the model and the actual practice. This may give strong support for the future clinical use of the platform.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| focused group | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biopsy of tumor before treatment | Other | samples obtained from biopsy will be used in the zebrafish PDX model |
|
| Measure | Description | Time Frame |
|---|---|---|
| The coincidence rate of tumor response obtained from 50 PDX models with clinical real tumor response acquired from corresponding patients received neoadjuvant therapy. | 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. | about 3 months (from the first cycle of neoadjuvant therapy to the surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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patients with advanced gastric cancer that will be treated with neoadjuvant chemotherapy, and surgery will be performed after 2 or 3 cycle of neoadjuvant therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoli Jin, Dr | Contact | 86-13605809870 | Jinxiaoli@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoli Jin, Dr | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| gastrointestinal department of second affiliated hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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tumor samples obtained before neoadjuvant treatment and would be transplanted the zebrafish model
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |