Organoid-Guided Chemotherapy for Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT04931381|
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : August 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Pancreatic Cancer||Other: Chemotherapy guided by organoid drug sensitivity test||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized, Controlled Trial of Chemotherapy for Advanced Pancreatic Cancer Based on Organoid Drug Sensitivity Test|
|Actual Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||May 31, 2024|
|Estimated Study Completion Date :||May 31, 2025|
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, Oxaliplatin, Irinotecan). Patients will receive relatively sensitive chemotherapy regimen based on the test results. Chemotherapy should start within 1 months after biopsy, and be given at least 1 cycle.
Other: Chemotherapy guided by organoid drug sensitivity test
Chemotherapy guided by organoid will be given to advanced pancreatic cancer patients.
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, Oxaliplatin, Irinotecan). Physician will decide the the adjuvant chemotherapy regimen, according to National Comprehensive Cancer Network (NCCN) guideline for pancreatic ductal adenocarcinoma. And they don't know the drug sensitivity test results. Chemotherapy should start within 1 months after biopsy, and be given at least 1 cycle.
- 6-month disease control rate [ Time Frame: 6 months ]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.
- Progression free time [ Time Frame: 1-2 years ]Time from the date of randomization to progression based on the radiology assessment of response using RECIST v1.1, or death, whichever is earlier.
- Overall survival time [ Time Frame: 1-2 years ]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.
- The successful establishment rate of organoids [ Time Frame: 1-2 years ]The rate of organoid successfully cultured in all the samples collected.
- Concordance between drug sensitivity test results and patients' treatment response (descriptive statistics). [ Time Frame: 1-2 years ]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
- Concordance between radiosensitivity test results and patients' treatment response (descriptive statistics). [ Time Frame: 1-2 years ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04931381
|Contact: Shiwei Guo, M.D.||+email@example.com|
|Contact: Huan Wang, Masterfirstname.lastname@example.org|
|Shanghai, China, 200433|
|Contact: Shiwei Guo, M.D. +8618621500666 email@example.com|
|Principal Investigator: Gang Jin, M.D.|
|Principal Investigator:||Gang Jin, M.D.||Changhai Hospital, Shanghai, China|