Clinical trial NCT06246630: In Vitro Organoid Drug Sensitivity-Guided Treatment for Advanced Pancreatic Neuroendocrine Tumor
Official title: A Prospective, Exploratory Study Evaluating the Effectiveness of Treatment Regimens for Locally Advanced/Metastatic Non-resectable Pancreatic Neuroendocrine Tumor (PNET) Guided by in Vitro Drug Sensitivity Testing of Tumor Organoids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Pancreatic Neuroendocrine Tumor
Keywords: p-NET
organoid
chemotherapy
target therapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Chongqing Kingbiotech Co.,Ltd
First posted: 2024-02-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective Response Rate
timeFrame: 1-2 years
Secondary outcomes:
measure: Progressive free survival
timeFrame: 1-2 years
measure: Overall survival time
timeFrame: 2 years
measure: The successful establishment rate of organoids
timeFrame: 1-2 years
measure: Concordance between drug sensitivity test results and patients' treatment response
timeFrame: 1-2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Jiabin JIN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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