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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Chemotherapy guided by organoid will be given to advanced pancreatic cancer patients.
Changhai Hospital
Shanghai, China
RECRUITING6-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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 1-2 years
The successful establishment rate of organoids
The rate of organoid successfully cultured in all the samples collected.
Time frame: 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
Time frame: 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
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Time frame: 1-2 years