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

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

NCT ID: NCT05842187

Condition: Pancreatic Cancer
Gastric Cancer

Conditions: Official terms:
Pancreatic Neoplasms
Stomach Neoplasms
Hypersensitivity

Conditions: Keywords:
pancreatic cancer
gastric cancer
organoid
drug sensitivity

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Biopsy of tumor tissue for organoid culture
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.
Arm group label: Organoid generation

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: The First Affiliated Hospital, Zhejiang University School of medicine

Address:
City: Hangzhou
Zip: 310009
Country: China

Status: Recruiting

Contact:
Last name: Jianzhen Shan

Phone: 0571-87235409
Email: jianzhenshan@163.com

Start date: March 3, 2023

Completion date: December 31, 2024

Lead sponsor:
Agency: Jianzhen Shan, MD
Agency class: Other

Source: First Affiliated Hospital of Zhejiang University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05842187