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

Trial ID: NCT06259058

Interventional - Phase 1/2 - Not yet recruiting

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).

Conditions

• Pancreatic Cancer

Interventions

• Irinotecan liposome injection
• Oxaliplatin
• 5-Fluorouracil
• Leucovorin
• SBRT

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.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Source: Clinicaltrials.gov

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