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In Vitro Organoid Drug Sensitivity-Guided Treatment for Metastatic Pancreatic and Gastric Cancer (ODYSSEY)

Primary Purpose

Pancreatic Cancer, Gastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Biopsy of tumor tissue for organoid culture
Sponsored by
Jianzhen Shan, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, gastric cancer, organoid, drug sensitivity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 and ≤ 75 years old. Metastatic pancreatic cancer with progression after second-line or higher treatment, metastatic gastric cancer with progression after third-line or higher treatment, or metastatic pancreatic or gastric cancer patients who cannot tolerate standard treatment regimens. Able to provide fresh tumor tissue specimens for organoid culture, including: ascites, pleural effusion, tumor biopsy tissues, tumor surgical specimens, etc. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2. Adequate organ function, including the following: Bone marrow: Absolute neutrophil count (ANC) in peripheral blood ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 80 g/L. Liver: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤ 3 times ULN. If liver metastases are present, aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤ 5 times ULN. Kidney: Creatinine clearance ≥ 45 mL/min (using the standard Cockcroft-Gault formula) or ≤ 1.5 times ULN. At least one measurable or evaluable lesion. For women: Must be sterilized, postmenopausal, or using highly effective contraception during treatment and for 3 months after treatment; must not be pregnant or breastfeeding during treatment. Patient compliance and geographic proximity to ensure adequate follow-up. Exclusion Criteria: Any unstable systemic disease (including systemic active infections requiring treatment, liver disease, kidney disease, or metabolic diseases, acute cerebral infarction or cerebral hemorrhage, etc.) that, in the investigator's judgment, may impair patient safety or the patient's ability to complete the study due to severe comorbidities. Significant cardiovascular events: Congestive heart failure > NYHA class 2; unstable angina, active coronary artery disease (CAD) (myocardial infarction more than 1 year before the study is allowed); severe arrhythmias requiring treatment (use of beta-blockers or digoxin is allowed) or uncontrolled hypertension, etc. Significant history of neurological or psychiatric disorders, including epilepsy, dementia, etc. Pregnant or breastfeeding women; those of childbearing potential who are unwilling or unable to use effective contraception. Other situations that the investigator judges may affect the conduct and determination of the clinical research results.

Sites / Locations

  • The First Affiliated Hospital, Zhejiang University School of medicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Organoid generation

Arm Description

All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation

Outcomes

Primary Outcome Measures

PFS (Progressive free survival)
The time from initiation of treatment to the occurrence of disease progression or death.

Secondary Outcome Measures

DCR (Disease control rate)
The percentage of patients who have achieved complete response, partial response and stable disease to a therapeutic intervention.

Full Information

First Posted
April 10, 2023
Last Updated
May 3, 2023
Sponsor
Jianzhen Shan, MD
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1. Study Identification

Unique Protocol Identification Number
NCT05842187
Brief Title
In Vitro Organoid Drug Sensitivity-Guided Treatment for Metastatic Pancreatic and Gastric Cancer
Acronym
ODYSSEY
Official Title
A Multi-center, Prospective, Exploratory Study Evaluating the Effectiveness of Treatment Regimens for Metastatic Pancreatic and Gastric Cancer Guided by in Vitro Drug Sensitivity Testing of Tumor Organoids
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jianzhen Shan, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to evaluate the consistency between in vitro tumor organoid drug sensitivity and the therapeutic efficacy of in vivo drug treatment. Participants are required to provide one of fresh tumor tissues (including ascites, pleural effusion, biopsy tissues, palliative surgery specimens, etc.) for the purpose of culturing tumor organoids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Gastric Cancer
Keywords
pancreatic cancer, gastric cancer, organoid, drug sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Organoid generation
Arm Type
Experimental
Arm Description
All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation
Intervention Type
Procedure
Intervention Name(s)
Biopsy of tumor tissue for organoid culture
Intervention Description
By collecting fresh tumor tissues (including ascites, pleural effusion, biopsy tissues, palliative surgery specimens, etc.) and culturing them into organoids in vitro, this study conducts drug sensitivity tests on various clinically approved drugs. The most sensitive drug for the patient is selected for treatment, and the study aims to evaluate the clinical effectiveness of the drug and its consistency with in vitro organoid drug sensitivity.
Primary Outcome Measure Information:
Title
PFS (Progressive free survival)
Description
The time from initiation of treatment to the occurrence of disease progression or death.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
DCR (Disease control rate)
Description
The percentage of patients who have achieved complete response, partial response and stable disease to a therapeutic intervention.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 and ≤ 75 years old. Metastatic pancreatic cancer with progression after second-line or higher treatment, metastatic gastric cancer with progression after third-line or higher treatment, or metastatic pancreatic or gastric cancer patients who cannot tolerate standard treatment regimens. Able to provide fresh tumor tissue specimens for organoid culture, including: ascites, pleural effusion, tumor biopsy tissues, tumor surgical specimens, etc. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2. Adequate organ function, including the following: Bone marrow: Absolute neutrophil count (ANC) in peripheral blood ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 80 g/L. Liver: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤ 3 times ULN. If liver metastases are present, aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤ 5 times ULN. Kidney: Creatinine clearance ≥ 45 mL/min (using the standard Cockcroft-Gault formula) or ≤ 1.5 times ULN. At least one measurable or evaluable lesion. For women: Must be sterilized, postmenopausal, or using highly effective contraception during treatment and for 3 months after treatment; must not be pregnant or breastfeeding during treatment. Patient compliance and geographic proximity to ensure adequate follow-up. Exclusion Criteria: Any unstable systemic disease (including systemic active infections requiring treatment, liver disease, kidney disease, or metabolic diseases, acute cerebral infarction or cerebral hemorrhage, etc.) that, in the investigator's judgment, may impair patient safety or the patient's ability to complete the study due to severe comorbidities. Significant cardiovascular events: Congestive heart failure > NYHA class 2; unstable angina, active coronary artery disease (CAD) (myocardial infarction more than 1 year before the study is allowed); severe arrhythmias requiring treatment (use of beta-blockers or digoxin is allowed) or uncontrolled hypertension, etc. Significant history of neurological or psychiatric disorders, including epilepsy, dementia, etc. Pregnant or breastfeeding women; those of childbearing potential who are unwilling or unable to use effective contraception. Other situations that the investigator judges may affect the conduct and determination of the clinical research results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Liu, MD
Phone
+86-571-87235409
Email
liuzhen@cancer.ac.cn
Facility Information:
Facility Name
The First Affiliated Hospital, Zhejiang University School of medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianzhen Shan
Phone
0571-87235409
Email
jianzhenshan@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

In Vitro Organoid Drug Sensitivity-Guided Treatment for Metastatic Pancreatic and Gastric Cancer

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