Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 10:08 PM
Study NCT ID:
NCT04931394
Status:
UNKNOWN
Last Update Posted:
2022-08-02
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Organoid-Guided Adjuvant Chemotherapy for Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-29', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free time', 'timeFrame': '1-2 years', 'description': 'Time from the date of randomization to recurrence based on the radiology assessment of response using RECIST v1.1, or death, whichever is earlier.'}], 'secondaryOutcomes': [{'measure': 'Overall survival time', 'timeFrame': '2-4 years', 'description': '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.'}, {'measure': '1-year disease-free survival', 'timeFrame': '1 year', 'description': 'The percentage of patients without recurrence by one year.'}, {'measure': 'The successful establishment rate of organoids', 'timeFrame': '2-4 years', 'description': 'The rate of organoid successfully cultured in all the samples collected.'}, {'measure': "Concordance between drug sensitivity test results and patients' treatment response (descriptive statistics).", 'timeFrame': '2-4 years', 'description': '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.'}, {'measure': "Concordance between radiosensitivity test results and patients' treatment response (descriptive statistics).", 'timeFrame': '2-4 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic Cancer', 'Organoid', 'Drug Sensitivity Test', 'Chemotherapy'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to explore whether adjuvant chemotherapy regimens guided by organoid drug sensitivity test can improve the outcomes of pancreatic cancer. At the same time, this study will evaluate the successful establishment rate of organoid from fresh surgical specimens , and explore the concordance between drug sensitivity test results and patients' treatment response.", 'detailedDescription': "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 adjuvant chemotherapy. Organoid is a new tumor model, which has the potential to test the drug sensitivity before chemotherapy.\n\nOur 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age≥18 years old and ≤80 years old.\n* Complete R0 resection for pancreatic cancer with no evidence of malignant ascites, peritoneal metastases or distant metastases.\n* Histology confirmed pancreatic adenocarcinoma.\n* Eligible histologic variants include adenocarcinoma or variants to include mucinous adenocarcinoma or adenosquamous carcinoma.\n* No metastases are found in preoperative examination.\n* No prior chemotherapy or radiotherapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy of greater than 90 days, as judged by the investigator.\n* Routine blood test: absolute neutrophil count\\>1500/mm3, platelet\\>100000/mm3.\n* 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.\n* Normal kidney function: serum creatinine\\<1.5 times of the upper limit of normal value or creatinine clearance rate\\>45ml/min.\n* The pancreatic cancer organoid were cultured successfully.\n* No severe comorbidities.\n\nExclusion Criteria:\n\n* Patients with poor condition can not tolerate chemotherapy and targeted therapy.\n* 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.\n* Patients diagnosed with other cancer within 5 years.\n* Patients who are pregnant or breastfeeding.\n* Patients enrolled in other clinical trials or incompliant of regular follow up.\n* Patients who did not provide an informed consent.'}, 'identificationModule': {'nctId': 'NCT04931394', 'briefTitle': 'Organoid-Guided Adjuvant Chemotherapy for Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'A Prospective, Randomized, Controlled Trial of Adjuvant Chemotherapy for Pancreatic Cancer Based on Organoid Drug Sensitivity Test', 'orgStudyIdInfo': {'id': 'ChanghaiH-PP08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Organoid-Guided Adjuvant Chemotherapy', 'description': '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.', 'interventionNames': ['Other: Adjuvant chemotherapy guided by organoid drug sensitivity test']}, {'type': 'NO_INTERVENTION', 'label': 'Physician-decided Adjuvant Chemotherapy', 'description': "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."}], 'interventions': [{'name': 'Adjuvant chemotherapy guided by organoid drug sensitivity test', 'type': 'OTHER', 'description': 'Adjuvant chemotherapy guided by organoid will be given to pancreatic cancer patients.', 'armGroupLabels': ['Organoid-Guided Adjuvant Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shiwei Guo, M.D.', 'role': 'CONTACT', 'email': 'gestwa@163.com', 'phone': '+8618621500666'}, {'name': 'Gang Jin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shiwei Guo, M.D.', 'role': 'CONTACT', 'email': 'gestwa@163.com', 'phone': '+8618621500666'}, {'name': 'Huan Wang, Master', 'role': 'CONTACT', 'email': 'mr_wang_huan@163.com', 'phone': '+8617317492841'}], 'overallOfficials': [{'name': 'Gang Jin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital, Shanghai, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor at the Institute of Pancreatic Surgery', 'investigatorFullName': 'Guo ShiWei', 'investigatorAffiliation': 'Changhai Hospital'}}}}