Status:
NOT_YET_RECRUITING
Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX
Lead Sponsor:
Changhai Hospital
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 rese...
Detailed Description
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 u...
Eligibility Criteria
Inclusion
- Age: ≥18 years old.
- Histologically or cytologically proven pancreatic ductal adenocarcinoma.
- Multidisciplinary assessment as high-risk resectable disease.
- At least one measurable lesion (according to RECIST v1.1).
- No prior antitumor therapy for pancreatic cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 \~ 1.
- The expected survival time ≥3 months.
- 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
- 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
- Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 × ULN or creatinine clearance ≥60 mL/min.
- Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.
Exclusion
- Any other malignancy within 5 years prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma.
- Patients with distant metastases and/or can not complete resection.
- Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
- Active HIV, HBV, HCV infection.
- 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.)
- Presence of severe gastrointestinal disease (including active bleeding, \> grade 1 obstruction \[CTCAE v5.0\], or \> grade 1 diarrhea \[CTCAE v5.0\])
- History of allergy or hypersensitivity to drug or any of their excipients.
- Patients who have chemotherapy and surgery contraindications.
- Documented serum albumin ≤3 g/dL
- Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.
- Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.
- Participated in other trial within 30 days prior to the first dose of study treatment.
- Patients who are not suitable to participate in this trial for any reason judged by the investigator
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT06210360
Start Date
February 1 2024
End Date
April 1 2027
Last Update
January 18 2024
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