NCT04931381

Organoid-Guided Chemotherapy for Advanced Pancreatic Cancer

A Prospective, Randomized, Controlled Trial of Chemotherapy for Advanced Pancreatic Cancer Based on Organoid Drug Sensitivity Test

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore whether chemotherapy regimens guided by organoid drug sensitivity test can improve the outcomes of advanced pancreatic cancer. 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

The poor prognosis of pancreatic cancer is not just because of the high malignancy of the tumor itself, but also its poor response to chemotherapy. At present, patient's drug-sensitivity is assessed by progression time after treatment. Therefore, it is difficult to judge a patient's sensitivity to a drug before chemotherapy. Organoid is a new tumor model, which has the potential to test the drug sensitivity before chemotherapy. Our center's previous experience has shown that the success rate of pancreatic cancer organoid culture is 77.6%. The previous research has confirmed that pancreatic cancer organoid was highly consistent with the original tissue in terms of genomics and histomorphology. More importantly, the investigators have tested the five first-line drug-sensitivity in 39 pancreatic cancer organoids, and compared the test results with the clinical treatment response of these patients, confirming that organoid can accurately evaluate the chemotherapy drug-sensitivity. This is a single-center, prospective, open-label, randomized, controlled clinical trial, designed to explore whether chemotherapy regimens guided by organoid drug sensitivity test can improve outcomes in advanced pancreatic cancer patients. At the same time, the consistency between the drug sensitivity test results and the treatment response of patients will be analyzed. Also, the radiosensitivity of organoids will be tested, and be compared with the patients' response to radiotherapy.

Conditions

• Advanced Pancreatic Cancer

Interventions

Type	Name	Description
OTHER	Chemotherapy guided by organoid drug sensitivity test	Chemotherapy guided by organoid will be given to advanced pancreatic cancer patients.

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-05-31
• Completion: 2025-05-31
• First posted: 2021-06-18
• Last updated: 2022-08-02

Locations

1 site across 1 country: China