Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 7:05 PM
Study NCT ID:
NCT06210360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2024-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C584112', 'term': 'irinotecan sucrosofate'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2024-01-02', 'studyFirstSubmitQcDate': '2024-01-17', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year Overall Survival Rate', 'timeFrame': '2 years', 'description': 'Defined as the percentage of patients who are alive at 2 years after randomization (proportion of patients alive will estimated by the survival curve)'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': '4 months', 'description': 'Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1'}, {'measure': 'Surgical Conversion Rate（R0 / R1 resection）', 'timeFrame': '5 months', 'description': 'Defined as the percentage of patients that underwent a R0/R1 resection'}, {'measure': 'R0 resection rate', 'timeFrame': '5 months', 'description': 'Defined as the proportion of patients who have achieved R0 resection'}, {'measure': 'Event-free Survival', 'timeFrame': '1 year', 'description': 'Defined as the time between signing the informed consent form to the first documentation of event where events considered are 1) disease progression (local recurrence, new lesions or distant metastasis), 2) a second malignant tumor occurs, or 3) death due to any cause'}, {'measure': 'Overall survival', 'timeFrame': '2 years', 'description': 'Defined as the time between signing the informed consent form and death due to various causes'}, {'measure': 'Incidence of adverse events', 'timeFrame': '7 months', 'description': 'Use NCI-CTCAE version 5.0 for classification and grading'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high-risk resectable', 'NALIRIFOX', 'perioperative'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This multicentric randomized trial will compare the efficacy and safety of neoadjuvant chemotherapy + surgery + adjuvant chemotherapy or surgery + adjuvant chemotherapy in patients with high-risk resectable pancreatic cancer. NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) will be used as the chemotherapy regimen.', 'detailedDescription': 'Liposomal irinotecan is a new pharmaceutical form of traditional irinotecan. It adopts a special loading technology to encapsulate traditional irinotecan in liposomes, which can avoid its hydrolysis under physiological conditions, increase the affinity with cancer cells, overcome drug resistance, increase the drug uptake by cancer cells, reduce the drug dose,improve the efficacy and reduce the toxic side effects. The aim of this study is to compare the efficacy and safety of NALIRIFOX + surgery + NALIRIFOX or surgery + NALIRIFOX in high-risk patients with resectable pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: ≥18 years old.\n2. Histologically or cytologically proven pancreatic ductal adenocarcinoma.\n3. Multidisciplinary assessment as high-risk resectable disease.\n4. At least one measurable lesion (according to RECIST v1.1).\n5. No prior antitumor therapy for pancreatic cancer.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 \\~ 1.\n7. The expected survival time ≥3 months.\n8. Subject has adequate biological parameters as demonstrated by the following blood counts:\n\n Absolute neutrophil count (ANC) ≥1.5×10\\^9/L Platelet count ≥100×10\\^9/L Hemoglobin (Hgb) ≥90 g/L White blood cell（WBC）≥3.0×10\\^9/L\n9. Adequate hepatic function as evidenced by:\n\n Serum total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) 、alkaline phosphatase（ALP）and alanine aminotransferase (ALT) ≤2.5 × ULN\n10. Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 × ULN or creatinine clearance ≥60 mL/min.\n11. Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.\n\nExclusion Criteria:\n\n1. Any other malignancy within 5 years prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma.\n2. Patients with distant metastases and/or can not complete resection.\n3. Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.\n4. Active HIV, HBV, HCV infection.\n5. Combined with uncontrollable systemic diseases (such as unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, severe pericardial disease history and other cardiovascular diseases; hypertension \\> grade 2 after medication \\[CTCAE v5.0\\], diabetes, etc.)\n6. Presence of severe gastrointestinal disease (including active bleeding, \\> grade 1 obstruction \\[CTCAE v5.0\\], or \\> grade 1 diarrhea \\[CTCAE v5.0\\])\n7. History of allergy or hypersensitivity to drug or any of their excipients.\n8. Patients who have chemotherapy and surgery contraindications.\n9. Documented serum albumin ≤3 g/dL\n10. Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.\n11. Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.\n12. Participated in other trial within 30 days prior to the first dose of study treatment.\n13. Patients who are not suitable to participate in this trial for any reason judged by the investigator'}, 'identificationModule': {'nctId': 'NCT06210360', 'briefTitle': 'Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'NALIRIFOX as Perioperative Treatment in Patients With High-risk Resectable Pancreatic Cancer : a Multicenter, Randomized, Open-label Trial', 'orgStudyIdInfo': {'id': 'CSPC-DEY-PC-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: NALIRIFOX + surgery + NALIRIFOX', 'description': 'Patients receive 8 cycles of NALIRIFOX. Then undergo surgery and receive 4 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV', 'interventionNames': ['Drug: Irinotecan liposome injection', 'Drug: Oxaliplatin', 'Drug: 5-FU', 'Drug: LV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: surgery + NALIRIFOX', 'description': 'Patients receive 12 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV.', 'interventionNames': ['Drug: Irinotecan liposome injection', 'Drug: Oxaliplatin', 'Drug: 5-FU', 'Drug: LV']}], 'interventions': [{'name': 'Irinotecan liposome injection', 'type': 'DRUG', 'otherNames': ['Nal-IRI'], 'description': '50 mg/m² on Day 1 of a 14 day cycle', 'armGroupLabels': ['Group A: NALIRIFOX + surgery + NALIRIFOX', 'Group B: surgery + NALIRIFOX']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['Eloxatin®'], 'description': '60 mg/m² on Day 1 of a 14 day cycle', 'armGroupLabels': ['Group A: NALIRIFOX + surgery + NALIRIFOX', 'Group B: surgery + NALIRIFOX']}, {'name': '5-FU', 'type': 'DRUG', 'otherNames': ['5-Fluorouracil', 'flurouracil', 'Adrucil®'], 'description': '2400 mg/m² continuous IV infusion in 46 h', 'armGroupLabels': ['Group A: NALIRIFOX + surgery + NALIRIFOX', 'Group B: surgery + NALIRIFOX']}, {'name': 'LV', 'type': 'DRUG', 'otherNames': ['Folinic Acid', 'Leucovorin'], 'description': '400 mg/m² on Day 1 of a 14 day cycle', 'armGroupLabels': ['Group A: NALIRIFOX + surgery + NALIRIFOX', 'Group B: surgery + NALIRIFOX']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Guo Shiwei, Professor', 'role': 'CONTACT', 'email': 'guoshiwei@163.com', 'phone': '18621500666'}], 'overallOfficials': [{'name': 'Jin Gang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}