Organoid-Guided Chemotherapy for Advanced Pancreatic Cancer
NCT ID: NCT04931381
Last Updated: 2022-08-02
Study Results
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Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2021-06-01
2025-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Chemotherapy guided by organoid drug sensitivity test
Chemotherapy guided by organoid will be given to advanced pancreatic cancer patients.
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.
No interventions assigned to this group
Interventions
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Chemotherapy guided by organoid drug sensitivity test
Chemotherapy guided by organoid will be given to advanced pancreatic cancer patients.
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed local advanced/metastatic pancreas adenocarcinoma.
* Eligible histologic variants include adenocarcinoma or variants to include mucinous adenocarcinoma or adenosquamous carcinoma.
* Patient must have a tumor lesion that is amenable to a core needle biopsy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of greater than 90 days, as judged by the investigator.
* Routine blood test: absolute neutrophil count\>1500/mm3, platelet\>100000/mm3.
* Normal liver function: serum total bilirubin≤2.0mg/dl, alanine aminotransferase (ALT) and aspertate aminotransferase (AST) \<2.5 times of the upper limit of normal value.
* Normal kidney function: serum creatinine\<1.5 times of the upper limit of normal value or creatinine clearance rate\>45ml/min.
* The pancreatic cancer organoid were cultured successfully.
* No severe comorbidities.
Exclusion Criteria
* Impaired organ functions: heart failure (New York Heart Association III-IV), coronary heart disease, myocardial infarction within 6 months, severe cardiac arrhythmia and respiratory failure.
* Patients diagnosed with other cancer within 5 years.
* Patients who are pregnant or breastfeeding.
* Patients enrolled in other clinical trials or incompliant of regular follow up.
* Patients who did not provide an informed consent.
18 Years
80 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Guo ShiWei
Associated Professor at the Institute of Pancreatic Surgery
Principal Investigators
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Gang Jin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital, Shanghai, China
Locations
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Changhai Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ChanghaiH-PP09
Identifier Type: -
Identifier Source: org_study_id
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