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Trial Title:
In Vitro Organoid Drug Sensitivity-Guided Treatment for Advanced Pancreatic Neuroendocrine Tumor
NCT ID:
NCT06246630
Condition:
Advanced Pancreatic Neuroendocrine Tumor
Conditions: Official terms:
Neuroendocrine Tumors
Adenoma, Islet Cell
Conditions: Keywords:
p-NET
organoid
chemotherapy
target therapy
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:
Other
Intervention name:
Chemotherapy and targeted-therapy guided by organoid drug sensitivity test
Description:
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-Guided therapy
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
jiabin JIN, PhD
Phone:
008602164370045
Phone ext:
670904
Email:
jjb11501@rjh.com.cn
Start date:
April 3, 2024
Completion date:
June 25, 2026
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
Chongqing Kingbiotech Co.,Ltd
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06246630
