Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer

Phase 1

Not yet recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: Irinotecan liposome injection; Drug: Oxaliplatin; Drug: 5-Fluorouracil; Drug: Leucovorin; Radiation: SBRT

• Registration Number: NCT06259058
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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).

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.
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Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-14
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Study Start: 2024-04-01
• Primary Completion: 2026-04-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NALIRIFOX + SBRT + NALIRIFOX + Surgery + NALIRIFOX	SBRT	Patients 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 + SBRT + NALIRIFOX + Surgery + NALIRIFOX	Irinotecan liposome injection	Patients 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 + SBRT + NALIRIFOX + Surgery + NALIRIFOX	5-Fluorouracil	Patients 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 + SBRT + NALIRIFOX + Surgery + NALIRIFOX	Oxaliplatin	Patients 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 + SBRT + NALIRIFOX + Surgery + NALIRIFOX	Leucovorin	Patients 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	Irinotecan liposome injection	Patients 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.
NALIRIFOX + Surgery + NALIRIFOX	Oxaliplatin	Patients 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.
NALIRIFOX + Surgery + NALIRIFOX	Leucovorin	Patients 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.
NALIRIFOX + Surgery + NALIRIFOX	5-Fluorouracil	Patients 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.

Primary Outcome Measures

Name	Time	Method
R0 resection rate	4 months	Defined as the proportion of patients who have achieved R0 resection.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	3 months	Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1
Surgical Conversion Rate (R0 / R1 resection)	4 months	Defined as the percentage of patients that underwent a R0/R1 resection.
Tumor regression grade	4 months	The classification is mainly based on the proportion of residual tumors and fibrosis in the primary tumor, used to evaluate the patient's response to neoadjuvant therapy and predict prognosis.
Event-free Survival	1 year	Defined as the time between signing the informed consent form to the first documentation of 1) disease progression (local recurrence, new lesions or distant metastasis), 2) a second malignant tumor occurs, or 3) death due to any cause.
Overall survival	2 years	Defined as the time between signing the informed consent form and death due to various causes.
Incidence of adverse events	7 months	Use NCI-CTCAE version 5.0 for classification and grading.