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

Pancreatic Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842187
• Other study ID #: IIT20230001C-R1
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Zhen Liu, MD
• Phone: +86-571-87235409
• Email: liuzhen[@]cancer.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Hypersensitivity
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Zhejiang University School of medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Jianzhen Shan, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS (Progressive free survival)	The time from initiation of treatment to the occurrence of disease progression or death.	6 months
Secondary	DCR (Disease control rate)	The percentage of patients who have achieved complete response, partial response and stable disease to a therapeutic intervention.	6 months