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

Not Applicable

Recruiting

• Conditions: Advanced Pancreatic Neuroendocrine Tumor
• Interventions: Other: Chemotherapy and targeted-therapy guided by organoid drug sensitivity test

• Registration Number: NCT06246630
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Study Start: 2024-04-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-12-25
• Study Completion: 2026-06-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Organoid-Guided therapy	Chemotherapy and targeted-therapy guided by organoid drug sensitivity test	All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation and drug sensitivity tests.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	1-2 years	Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1.

Secondary Outcome Measures

Name	Time	Method
The successful establishment rate of organoids	1-2 years	The rate of organoid successfully cultured in all the samples collected.
Concordance between drug sensitivity test results and patients' treatment response	1-2 years	To assess the accuracy of drug sensitivity test in both group. The number of patients with correct prediction of treatment response by organoid drug-sensitivity test divided by the number of patients underwent chemotherapy
Overall survival time	2 years	The time from the date of randomization to the date of death for any cause. Patients will be followed until their date of death or until final database closure.
Progressive free survival	1-2 years	The time from initiation of treatment to the occurrence of disease progression or death.

Trial Locations

Locations (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China