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

NCT ID: NCT05842187

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-03
• Study Completion Date: 2024-12-31

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.

Conditions

Pancreatic Cancer; Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Organoid generation

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

Group Type: EXPERIMENTAL

Biopsy of tumor tissue for organoid culture

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jianzhen Shan, MD

OTHER

Sponsor Role: lead

Responsible Party

Jianzhen Shan, MD

Director of Medical Oncology Department (4)

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Affiliated Hospital, Zhejiang University School of medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhen Liu, MD

Role: CONTACT

liuzhen@cancer.ac.cn

+86-571-87235409

Facility Contacts

Jianzhen Shan

Role: primary

jianzhenshan@163.com

0571-87235409

Other Identifiers

IIT20230001C-R1

Identifier Type: -

Identifier Source: org_study_id