Personalized Management of Pancreatic Adenocarcinoma Using Patient-Derived Tumoroids

Study Overview
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Brief Summary
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This study is designed to prospectively investigate the feasibility of establishing patient-derived tumoroids (PDT) as a platform for a personalized approach for response prediction and guide optimal neoadjuvant and/or adjuvant approach. PDT will be investigated to determine drug sensitivity, predict the response to chemotherapy agents and radiation therapy, and validate this response in treated patients, and to establish the feasibility of PDT as a platform for a personalized approach to guide multimodality treatment.

Official Title
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Establishing a Platform for Personalized Approach to the Management of Pancreatic Adenocarcinoma Using Patient-Derived Tumoroids

Conditions
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Pancreas Adenocarcinoma

Intervention / Treatment
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* Other: Treatment prediction PDT platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years of age. Have an ECOG Performance Status of ≤ 2. No evidence of distant metastasis on imaging. Histologic or cytologic proven adenocarcinoma of the pancreas. Providing informed consent prior to enrollment in the trial. Exclusion Criteria: Failure to obtain additional core needle biopsies for generating PDTs. Females who are pregnant or plan to become pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tumoroid generation<br>Single arm, including all the patients enrolled to generate tumor models | Other: Treatment prediction PDT platform<br>* PDT will be generated and response to various chemotherapies and radiation will be investigated. Actionable targets will be identified and response to the target drug will be assessed and compared to the conventional treatment options.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of the successful establishment of pancreatic patient-derived tumoroids (PDT) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug sensitivity and response prediction of chemotherapy agents in PDT | the PDT response to the treatment with conventional regimens for treatment of (pancreatic adenocarcinoma (PDAC) and other approved treatments based on pharmacogenomic analysis. Treatment response will be assessed with viability assays. | 2 years | 
| Drug sensitivity and response prediction of radiation therapy in PDT | the PDT response to the treatment with radiation with or without radiosensitizers. Treatment response will be assessed with viability assays. | 2 years | 
| PDT validation with a comparative analysis of patients' response to neoadjuvant chemotherapy and radiation | Response evaluation according to imaging based on RECIST (Response Evaluation Criteria in Solid Tumors) criteria, biochemical response in CA19-9 and pathologic response in the surgical specimen vs. PTD response in the corresponding neoadjuvant regimen. | 2 years |