Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Irinotecan liposome injection, Oxaliplatin, 5-Fluorouracil, Leucovorin.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluate the Efficacy and Safety of Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer: a Phase Ib/II, Multicenter, Open-label Trial
Overview
This multicentric open-label trial will compare the efficacy and safety of stereotactic body radiation therapy (SBRT) followed by NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) vs NALIRIFOX for borderline resectable pancreatic cancer (BRPC).
Detailed description
Neoadjuvant chemotherapy or chemoradiotherapy can increase the R0 resection rate and improve survival in BRPC. However, there is no standard treatment regimen. The National Comprehensive Cancer Network (NCCN) guidelines recommend FOLFIRINOX (irinotecan + oxaliplatin +5-FU/LV) and FOLFIRINOX+ chemoradiotherapy for PDAC neoadjuvant treatment.
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.
Interventions
- Drug Irinotecan liposome injection
50 mg/m² on Day 1 of a 14-day cycle - Drug Oxaliplatin
60 mg/m² on Day 1 of a 14-day cycle - Drug 5-Fluorouracil
2400 mg/m² continuous IV infusion in 46 h - Drug Leucovorin
400 mg/m² on Day 1 of a 14-day cycle - Radiation SBRT
30Gy/5Fx
Primary outcome measures
- R0 resection rate [Time frame: 4 months]
Secondary outcome measures (6)
- Objective Response Rate [Time frame: 3 months]
- Surgical Conversion Rate (R0 / R1 resection) [Time frame: 4 months]
- Tumor regression grade [Time frame: 4 months]
- Event-free Survival [Time frame: 1 year]
- Overall survival [Time frame: 2 years]
- Incidence of adverse events [Time frame: 7 months]
Eligibility criteria
Inclusion criteria
- Age: ≥18 years old.
- Histologically or cytologically proven pancreatic ductal adenocarcinoma.
- Multidisciplinary assessment as borderline 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.
- Adequate bone marrow function as evidenced by: 1) Absolute neutrophil count (ANC) ≥1.5×10\^9/L, 2) Platelet count ≥100×10\^9/L, 3) Hemoglobin (Hb) ≥90 g/L, 4) White blood cell (WBC) ≥3.0×10\^9/L.
- Adequate hepatic function as evidenced by: 1) Serum total bilirubin ≤1.5 × upper limit of normal (ULN), 2) Aspartate aminotransferase (AST) 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 criteria
- Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.
- Patients with distant metastases and/or cannot complete resection.
- Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
- Active HIV, HBV, HCV infection.
- Combined with uncontrollable systemic diseases.
- 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 within 14 days before the first administration.
- Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.
- Participated in other trial within 30 days before the first administration.
- Patients who are not suitable to participate in this trial for any reason judged by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06259058 · CSPC-DEY-PC-K04