Organoid-Guided Adjuvant Chemotherapy for Pancreatic Cancer
NCT ID: NCT04931394
Last Updated: 2022-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 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 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Organoid-Guided Adjuvant Chemotherapy
The pancreatic cancer specimens are obtained from surgery 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. Adjuvant chemotherapy should start within 2 months after surgery, and last at least 6 months.
Adjuvant chemotherapy guided by organoid drug sensitivity test
Adjuvant chemotherapy guided by organoid will be given to pancreatic cancer patients.
Physician-decided Adjuvant Chemotherapy
The pancreatic cancer specimens are obtained from surgery 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. Adjuvant chemotherapy should start within 2 months after surgery, and last at least 6 months.
No interventions assigned to this group
Interventions
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Adjuvant chemotherapy guided by organoid drug sensitivity test
Adjuvant chemotherapy guided by organoid will be given to pancreatic cancer patients.
Eligibility Criteria
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Inclusion Criteria
* Complete R0 resection for pancreatic cancer with no evidence of malignant ascites, peritoneal metastases or distant metastases.
* Histology confirmed pancreatic adenocarcinoma.
* Eligible histologic variants include adenocarcinoma or variants to include mucinous adenocarcinoma or adenosquamous carcinoma.
* No metastases are found in preoperative examination.
* No prior chemotherapy or radiotherapy.
* 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, 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-PP08
Identifier Type: -
Identifier Source: org_study_id
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