Using organoid drug sensitivity tests to guide treatment for advanced pancreatic neuroendocrine tumors

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

This study is testing if using lab-grown mini tumors to see how they react to different drugs can help improve treatment for patients with advanced pancreatic neuroendocrine tumors.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ruijin Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06246630 on ClinicalTrials.gov

What this trial studies

This study aims to determine if chemotherapy and targeted therapies, guided by organoid drug sensitivity tests, can enhance treatment outcomes for patients with non-resectable locally advanced and metastatic pancreatic neuroendocrine tumors (p-NET). It will enroll twenty patients who will provide tumor samples for creating patient-derived organoids (PDOs). These organoids will be treated with various drugs, and their growth will be monitored to assess drug effectiveness. The study will also evaluate the correlation between organoid responses and actual patient treatment outcomes using imaging techniques.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed locally advanced or metastatic pancreatic neuroendocrine tumors who cannot undergo surgery.

Not a fit: Patients with other malignancies, severe cardiovascular events, or psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients with advanced pancreatic neuroendocrine tumors.

How similar studies have performed: While the use of organoid models in drug sensitivity testing is gaining traction, this specific application in advanced pancreatic neuroendocrine tumors is relatively novel.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Jiabin JIN, PhD — Ruijin Hospital
• Study coordinator: Jiabin JIN, PhD

Conditions: Advanced Pancreatic Neuroendocrine Tumor, p-NET, organoid, chemotherapy, target therapy