NCT04931394

Organoid-Guided Adjuvant Chemotherapy for Pancreatic Cancer

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (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 adjuvant chemotherapy regimens guided by organoid drug sensitivity test can improve the outcomes of pancreatic cancer. At the same time, this study will evaluate the successful establishment rate of organoid from fresh surgical specimens , 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 adjuvant 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 adjuvant chemotherapy regimens guided by organoid drug sensitivity test can improve outcomes in 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 organoid will be tested, and be compared with the patients' response to radiotherapy.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
OTHER	Adjuvant chemotherapy guided by organoid drug sensitivity test	Adjuvant chemotherapy guided by organoid will be given to 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