In Vitro Organoid Drug Sensitivity-Guided Treatment for Advanced Pancreatic Neuroendocrine Tumor

NCT ID: NCT06246630

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-03
• Study Completion Date: 2026-06-25

Brief Summary

The purpose of this study is to explore whether chemotherapy and targeted-therapy regimens guided by organoid drug sensitivity test can improve the outcomes of non-resectable locally advanced and metastatic Pancreatic neuroendocrine tumors. At the same time, this study will evaluate the successful stablishment rate of organoid from biopsy tissue , and explore the concordance between drug sensitivity test results and patients' treatment response

Detailed Description

Twenty non-resectable locally advanced and metastatic pancreatic neuroendocrine Tumor(p-NET) patients who should receive palliative treatment will be enrolled in this study. Baseline information of the enrolled patients including medical history, physical examination records and clinical examination records will be collected. Tumor material of those patients will be obtained from Pancreatic endoscopic biopsies or surgical resection. Patient-derived organoids (PDOs) will be established and cultured from p-NET tumor specimens. PDOs will then be treated with drugs of the chemotherapeutic and targeted therapeutic regimens for p-NET. Organoid size and growth will be monitored before and after the treatment, and dose-response curves will be generated. As for the assessment of clinical outcomes of patients, treatment responses will be assessed by biomedical imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1). Consistency between treatment responses in PDO models and clinical outcomes of patients will be assessed by correlation analysis.

Conditions

Advanced Pancreatic Neuroendocrine Tumor

Study Design

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

Study Groups

Organoid-Guided therapy

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

Group Type: EXPERIMENTAL

Chemotherapy and targeted-therapy guided by organoid drug sensitivity test

Intervention Type: OTHER

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

Chemotherapy and targeted-therapy guided by organoid drug sensitivity test

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: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 and ≤ 75 years old.

2. Histologically or cytologically confirmed locally advanced/metastatic Pancreatic Neuroendocrine Tumor

3. Surgery was considered impossible or can not receive the radical purpose.

4. Able to provide fresh tumor tissue specimens for organoid culture, including: tumor biopsy tissues, tumor surgical specimens, etcy.

5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.

6. Expected survival time≥ six months.

7. Patient have been informed and consented, compliance and geographic proximity to ensure adequate follow-up

Exclusion Criteria

1. Other malignancies in the past 5 years, excluding cured basal cell carcinoma of the skin.

2. History of severe cardiovascular events and myocardial Infarction within twelve months before the study.

3. Patients with psychiatric disorders or with psychotropic substance abuse and inability to abstain.

4. Pregnant or breastfeeding women.

5. According to researcher's consideration, patients with other serious systemic diseases or other conditions that are not suitable for participation.

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

Sponsors

Chongqing Kingbiotech Co.,Ltd

UNKNOWN

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

JIABIN JIN

Associate Chief Physician, Pancreatic Disease Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiabin JIN, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiabin JIN, PhD

Role: CONTACT

jjb11501@rjh.com.cn

008618101870031

Facility Contacts

jiabin JIN, PhD

Role: primary

jjb11501@rjh.com.cn

008602164370045 ext. 670904

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Other Identifiers

Ruijin20231007060328844

Identifier Type: -

Identifier Source: org_study_id