Stereotactic Body Radiation Therapy Followed By NALIRIFOX Vs NALIRIFOX For Borderline Resectable Pancreatic Cancer

Study Overview

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

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).

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.

Pancreatic Cancer

DRUG: Irinotecan liposome injection
DRUG: Oxaliplatin
DRUG: 5-Fluorouracil
DRUG: Leucovorin
RADIATION: SBRT

CSPC-DEY-PC-K04

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-02-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-14
First Submitted that Met QC Criteria 2024-02-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-03-15
First Posted (ACTUAL) 2024-02-14	Results First Posted N/A	Last Verified 2024-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: NALIRIFOX + SBRT + NALIRIFOX + Surgery + NALIRIFOX 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.	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
ACTIVE_COMPARATOR: NALIRIFOX + Surgery + NALIRIFOX 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.	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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: NALIRIFOX + SBRT + NALIRIFOX + Surgery + NALIRIFOX

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.

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

ACTIVE_COMPARATOR: NALIRIFOX + Surgery + NALIRIFOX

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.

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	Measure Description	Time Frame
R0 resection rate	Defined as the proportion of patients who have achieved R0 resection.	4 months

Secondary Outcome Measures	Measure Description	Time Frame
Objective Response Rate	Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1	3 months
Surgical Conversion Rate (R0 / R1 resection)	Defined as the percentage of patients that underwent a R0/R1 resection.	4 months
Tumor regression grade	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.	4 months
Event-free Survival	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.	1 year
Overall survival	Defined as the time between signing the informed consent form and death due to various causes.	2 years
Incidence of adverse events	Use NCI-CTCAE version 5.0 for classification and grading.	7 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Chuntao Gao, Professor

Phone Number: 022-2340123

Email: gaochuntao@tjmuch.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Jihui Hao, Professor, Tianjin Medical University Cancer Institute and Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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