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

NCT ID: NCT06259058

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2027-12-01

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.

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Irinotecan liposome injection

Intervention Type: DRUG

50 mg/m² on Day 1 of a 14-day cycle

Oxaliplatin

Intervention Type: DRUG

60 mg/m² on Day 1 of a 14-day cycle

5-Fluorouracil

Intervention Type: DRUG

2400 mg/m² continuous IV infusion in 46 h

Leucovorin

Intervention Type: DRUG

400 mg/m² on Day 1 of a 14-day cycle

SBRT

Intervention Type: RADIATION

30Gy/5Fx

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.

Group Type: ACTIVE_COMPARATOR

Irinotecan liposome injection

Intervention Type: DRUG

50 mg/m² on Day 1 of a 14-day cycle

Oxaliplatin

Intervention Type: DRUG

60 mg/m² on Day 1 of a 14-day cycle

5-Fluorouracil

Intervention Type: DRUG

2400 mg/m² continuous IV infusion in 46 h

Leucovorin

Intervention Type: DRUG

400 mg/m² on Day 1 of a 14-day cycle

Interventions

Irinotecan liposome injection

50 mg/m² on Day 1 of a 14-day cycle

Intervention Type: DRUG

Oxaliplatin

60 mg/m² on Day 1 of a 14-day cycle

Intervention Type: DRUG

5-Fluorouracil

2400 mg/m² continuous IV infusion in 46 h

Intervention Type: DRUG

Leucovorin

400 mg/m² on Day 1 of a 14-day cycle

Intervention Type: DRUG

SBRT

30Gy/5Fx

Intervention Type: RADIATION

Other Intervention Names

Nal-IRI; Eloxatin; 5-FU; flurouracil; Adrucil; Folinic Acid

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jihui Hao, Professor

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Central Contacts

Chuntao Gao, Professor

Role: CONTACT

gaochuntao@tjmuch.com

022-2340123 ext. 3077

Other Identifiers

CSPC-DEY-PC-K04

Identifier Type: -

Identifier Source: org_study_id