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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06259058
• Other study ID #: CSPC-DEY-PC-K04
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 1, 2024
• Est. completion date: December 1, 2027

Study information

• Verified date: February 2024
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Chuntao Gao, Professor
• Phone: 022-2340123
• Email: gaochuntao[@]tjmuch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: December 1, 2027
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

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-Fluorouracil
2400 mg/m² continuous IV infusion in 46 h
• Leucovorin
400 mg/m² on Day 1 of a 14-day cycle

Radiation:
• SBRT
30Gy/5Fx

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 resection rate	Defined as the proportion of patients who have achieved R0 resection.	4 months
Secondary	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
Secondary	Surgical Conversion Rate (R0 / R1 resection)	Defined as the percentage of patients that underwent a R0/R1 resection.	4 months
Secondary	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
Secondary	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
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