Ignite Creation Date:
2024-05-06 @ 6:18 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05616533
Status:
RECRUITING
Last Update Posted:
2023-12-26
First Post:
2022-11-07
Brief Title:
Evaluation of Consistency of PDX Model for Predicting Therapeutic Effect of Gastric Cancer
Sponsor:
Zhejiang University
Organization:
Zhejiang University
Study Overview
Official Title:
Consistency Evaluation of a Patient-derived Tumor Xenograft Zebrafish Model in Predicting Anti-cancer Efficacy of Conventional Drugs for Gastric Cancer
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 xenograftPDX 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
Detailed Description:
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 CDXPDX 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None