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

May 3, 2023 updated by: Jianzhen Shan, MD

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 75 years old.
  2. 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.
  3. Able to provide fresh tumor tissue specimens for organoid culture, including: ascites, pleural effusion, tumor biopsy tissues, tumor surgical specimens, etc.
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.

  5. 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.
  6. At least one measurable or evaluable lesion.
  7. 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.
  8. Patient compliance and geographic proximity to ensure adequate follow-up.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Significant history of neurological or psychiatric disorders, including epilepsy, dementia, etc.
  4. Pregnant or breastfeeding women; those of childbearing potential who are unwilling or unable to use effective contraception.
  5. Other situations that the investigator judges may affect the conduct and determination of the clinical research results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Organoid generation
All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation
Procedure: Biopsy of tumor tissue for organoid culture
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS (Progressive free survival)
Time Frame: 6 months
The time from initiation of treatment to the occurrence of disease progression or death.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DCR (Disease control rate)
Time Frame: 6 months
The percentage of patients who have achieved complete response, partial response and stable disease to a therapeutic intervention.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jianzhen Shan, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

April 10, 2023

First Submitted That Met QC Criteria

April 22, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT20230001C-R1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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