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2021-06-01
2024-05-31
2025-05-31
100
NCT04931381
Changhai Hospital
Changhai Hospital
INTERVENTIONAL
Organoid-Guided Chemotherapy for Advanced Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-06-15 | N/A | 2022-07-29 |
2021-06-15 | N/A | 2022-08-02 |
2021-06-18 | N/A | 2022-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Organoid-Guided Chemotherapy The pancreatic cancer specimens are obtained from biopsy to be cultured for organoids. Then drug sensitivity is tested using organoid to obtain the sensitivity to the first-line drugs for pancreatic cancer (Gemcitabine, 5-fluorouracil, Paclitaxel, Oxalipl | OTHER: Chemotherapy guided by organoid drug sensitivity test
|
| NO_INTERVENTION: Physician-decided Chemotherapy The pancreatic cancer specimens are obtained from biopsy to be cultured for organoids. Then drug sensitivity is tested using organoid to obtain the sensitivity to the first-line drugs for pancreatic cancer (Gemcitabine, 5-fluorouracil, Paclitaxel, Oxalipl |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 6-month disease control rate | Percentage of patient's measurable disease who have achieved either complete response (CR) , partial response (PR) or stable disease (SD) according to RECIST 1.1. | 6 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression free time | Time from the date of randomization to progression based on the radiology assessment of response using RECIST v1.1, or death, whichever is earlier. | 1-2 years |
| Overall survival time | 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. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be alive or at the date of event cut-off for Overall survival (OS) analysis. | 1-2 years |
| The successful establishment rate of organoids | The rate of organoid successfully cultured in all the samples collected. | 1-2 years |
| Concordance between drug sensitivity test results and patients' treatment response (descriptive statistics). | 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 | 1-2 years |
| Concordance between radiosensitivity test results and patients' treatment response (descriptive statistics). | To assess the accuracy of radiosensitivity test in both group. The number of patients with correct prediction of treatment response by organoid radiosensitivity test divided by the number of patients underwent radiotherapy | 1-2 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Shiwei Guo, M.D. Phone Number: +8618621500666 Email: gestwa@163.com |
Study Contact Backup Name: Huan Wang, Master Phone Number: +8617317492841 Email: mr_wang_huan@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
