Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX
NCT ID: NCT06210360
Last Updated: 2024-01-18
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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NOT_YET_RECRUITING
PHASE2
134 participants
INTERVENTIONAL
2024-02-01
2027-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: NALIRIFOX + surgery + NALIRIFOX
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
Irinotecan liposome injection
50 mg/m² on Day 1 of a 14 day cycle
Oxaliplatin
60 mg/m² on Day 1 of a 14 day cycle
5-FU
2400 mg/m² continuous IV infusion in 46 h
LV
400 mg/m² on Day 1 of a 14 day cycle
Group B: surgery + NALIRIFOX
Patients receive 12 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV.
Irinotecan liposome injection
50 mg/m² on Day 1 of a 14 day cycle
Oxaliplatin
60 mg/m² on Day 1 of a 14 day cycle
5-FU
2400 mg/m² continuous IV infusion in 46 h
LV
400 mg/m² on Day 1 of a 14 day cycle
Interventions
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Irinotecan liposome injection
50 mg/m² on Day 1 of a 14 day cycle
Oxaliplatin
60 mg/m² on Day 1 of a 14 day cycle
5-FU
2400 mg/m² continuous IV infusion in 46 h
LV
400 mg/m² on Day 1 of a 14 day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically proven pancreatic ductal adenocarcinoma.
3. Multidisciplinary assessment as high-risk resectable disease.
4. At least one measurable lesion (according to RECIST v1.1).
5. No prior antitumor therapy for pancreatic cancer.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 \~ 1.
7. The expected survival time ≥3 months.
8. Subject has adequate biological parameters as demonstrated by the following blood counts:
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
9. Adequate hepatic function as evidenced by:
Serum total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) 、alkaline phosphatase（ALP）and alanine aminotransferase (ALT) ≤2.5 × ULN
10. Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 × ULN or creatinine clearance ≥60 mL/min.
11. Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.
Exclusion Criteria
2. Patients with distant metastases and/or can not complete resection.
3. Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
4. Active HIV, HBV, HCV infection.
5. 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.)
6. Presence of severe gastrointestinal disease (including active bleeding, \> grade 1 obstruction \[CTCAE v5.0\], or \> grade 1 diarrhea \[CTCAE v5.0\])
7. History of allergy or hypersensitivity to drug or any of their excipients.
8. Patients who have chemotherapy and surgery contraindications.
9. Documented serum albumin ≤3 g/dL
10. Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.
11. Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.
12. Participated in other trial within 30 days prior to the first dose of study treatment.
13. Patients who are not suitable to participate in this trial for any reason judged by the investigator
18 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Principal Investigators
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Jin Gang, Professor
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Central Contacts
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Other Identifiers
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CSPC-DEY-PC-03
Identifier Type: -
Identifier Source: org_study_id
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