Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX

Pancreatic Cancer Clinical Trial

Official title:

NALIRIFOX as Perioperative Treatment in Patients With High-risk Resectable Pancreatic Cancer : a Multicenter, Randomized, Open-label Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06210360
• Other study ID #: CSPC-DEY-PC-03
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 1, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: December 2023
• Source: Changhai Hospital
• Contact: Guo Shiwei, Professor
• Phone: 18621500666
• Email: guoshiwei[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 resectable pancreatic cancer. NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) will be used as the chemotherapy regimen.

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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 134
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age: =18 years old.

2. Histologically or cytologically proven pancreatic ductal adenocarcinoma.

3. Multidisciplinary assessment as high-risk resectable disease.

4. At least one measurable lesion (according to RECIST v1.1).

5. No prior antitumor therapy for pancreatic cancer.

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 1.

7. The expected survival time =3 months.

8. 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

9. 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

10. Adequate renal function as evidenced by serum creatinine (Cr)=1.5 × ULN or creatinine clearance =60 mL/min.

11. Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.

Exclusion Criteria:

1. Any other malignancy within 5 years prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma.

2. Patients with distant metastases and/or can not complete resection.

3. Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.

4. Active HIV, HBV, HCV infection.

5. 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.)

6. Presence of severe gastrointestinal disease (including active bleeding, > grade 1 obstruction [CTCAE v5.0], or > grade 1 diarrhea [CTCAE v5.0])

7. History of allergy or hypersensitivity to drug or any of their excipients.

8. Patients who have chemotherapy and surgery contraindications.

9. Documented serum albumin =3 g/dL

10. Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.

11. Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.

12. Participated in other trial within 30 days prior to the first dose of study treatment.

13. Patients who are not suitable to participate in this trial for any reason judged by the investigator

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Irinotecan liposome injection
50 mg/m² on Day 1 of a 14 day cycle
• Oxaliplatin
60 mg/m² on Day 1 of a 14 day cycle
• 5-FU
2400 mg/m² continuous IV infusion in 46 h
• LV
400 mg/m² on Day 1 of a 14 day cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year Overall Survival Rate	Defined as the percentage of patients who are alive at 2 years after randomization (proportion of patients alive will estimated by the survival curve)	2 years
Secondary	Objective Response Rate	Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1	4 months
Secondary	Surgical Conversion Rate(R0 / R1 resection)	Defined as the percentage of patients that underwent a R0/R1 resection	5 months
Secondary	R0 resection rate	Defined as the proportion of patients who have achieved R0 resection	5 months
Secondary	Event-free Survival	Defined as the time between signing the informed consent form to the first documentation of event where events considered are 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
Secondary	Overall survival	Defined as the time between signing the informed consent form and death due to various causes	2 years
Secondary	Incidence of adverse events	Use NCI-CTCAE version 5.0 for classification and grading	7 months