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

Last updated: May 14, 2024
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoid Syndrome And Carcinoid Tumours

Abdominal Cancer

Digestive System Neoplasms

Treatment

Chemotherapy and targeted-therapy guided by organoid drug sensitivity test

Clinical Study ID

NCT06246630
Ruijin20231007060328844
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 75 years old.

  2. Histologically or cytologically confirmed locally advanced/metastatic PancreaticNeuroendocrine 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: tumorbiopsy 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 toensure adequate follow-up

Exclusion

Exclusion Criteria:

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

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

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

  4. Pregnant or breastfeeding women.

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

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Chemotherapy and targeted-therapy guided by organoid drug sensitivity test
Phase:
Study Start date:
April 03, 2024
Estimated Completion Date:
June 25, 2026

Study 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.

Connect with a study center

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

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