Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer
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
1 other identifier
interventional
96
0 countries
N/A
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 pancreatic-cancer
Started Apr 2024
Typical duration for phase_1 pancreatic-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2024
CompletedFirst Posted
Study publicly available on registry
February 14, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedMarch 15, 2024
February 1, 2024
2 years
February 6, 2024
March 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
R0 resection rate
Defined as the proportion of patients who have achieved R0 resection.
4 months
Secondary Outcomes (6)
Objective Response Rate
3 months
Surgical Conversion Rate (R0 / R1 resection)
4 months
Tumor regression grade
4 months
Event-free Survival
1 year
Overall survival
2 years
- +1 more secondary outcomes
Study Arms (2)
NALIRIFOX + SBRT + NALIRIFOX + Surgery + NALIRIFOX
EXPERIMENTALPatients receive 3 cycles of NALIRIFOX followed by SBRT (30Gy/5Fx). Then undergo surgery and receive 6 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV.
NALIRIFOX + Surgery + NALIRIFOX
ACTIVE COMPARATORPatients receive 6 cycles of NALIRIFOX. Then undergo surgery and receive 6 cycles of NALIRIFOX after surgery. NALIRIFOX consists of irinotecan liposome injection, oxaliplatin, 5 FU/LV.
Interventions
50 mg/m² on Day 1 of a 14-day cycle
60 mg/m² on Day 1 of a 14-day cycle
2400 mg/m² continuous IV infusion in 46 h
400 mg/m² on Day 1 of a 14-day cycle
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jihui Hao, Professor
Tianjin Medical University Cancer Institute and Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2024
First Posted
February 14, 2024
Study Start
April 1, 2024
Primary Completion
April 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
March 15, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share