Liposomal irinotecan combined with oxaliplatin, 5-fluorouracil/leucovorin with or without camrelizumab as preoperative chemotherapy for borderline resectable pancreatic cancer: Preliminary results of a single-center phase II exploratory study.

e16465 Background: Borderline resectable pancreatic cancer (BRPC) lacks established standard preoperative chemotherapy regimens to improve resectability and long-term outcomes. This single-center phase II exploratory study evaluated the efficacy and safety of liposomal irinotecan + oxaliplatin + 5-fluorouracil/leucovorin (5-FU/LV) with/without camrelizumab as preoperative chemotherapy for BRPC(NCT06345300). Methods: This was a single-center, open-label, randomized phase II study. Eligible patients had histologically/cytologically confirmed BRPC, ECOG PS 0-1, and no prior systemic antineoplastic therapy. Patients were randomized to two cohorts: Cohort 1 (immunechemotherapy): liposomal irinotecan (56.5 mg/m², IV, Day 1) + oxaliplatin (85 mg/m², IV, Day 1) + 5-FU (2400 mg/m², IV, continuous infusion 46-48h, Day 1) + LV (200 mg/m², IV, Day 1) + camrelizumab (200 mg, IV, Day 1, q2w); Cohort 2 (chemotherapy): same regimen excluding camrelizumab. Both cohorts received 3 preoperative cycles (14 days/cycle). Efficacy was assessed per RECIST v1.1, safety per NCI-CTCAE v5.0. Primary endpoint: R0 resection rate; secondary endpoints: objective response rate (ORR), disease control rate (DCR), and safety profile. Results: As of Jan 17, 2026, 21 patients were enrolled in the intention-to-treat (ITT) population (Cohort 1: 12 57.1%; Cohort 2: 9 42.9%). Median age was 60.7 years (Cohort 1) and 60.25 years (Cohort 2). Efficacy was evaluable in 14 patients (Cohort 1: 8; Cohort 2: 6). Cohort 1: ORR 37.5% (3/8), DCR 62.5% (5/8); Cohort 2: ORR 33.3% (2/6), DCR 83.3% (5/6). Four patients (19.0% of ITT) underwent surgical exploration (Cohort 1: 1; Cohort 2: 3), all achieving R0 resection (100% R0 rate). Pathological re-staging: Cohort 1 (1 case: ypT1N0); Cohort 2 (1 ypT2N0, 1 ypT2N1, 1 ypT3N0). Safety was evaluable in all 21 ITT patients. Cohort 1: most common all-grade AEs were nausea (69.2%), diarrhea (50.0%), neutropenia (41.7%), constipation (33.3%); Grade ≥3 AEs included neutropenia (25.0%), malnutrition (16.7%), leukopenia (8.3%), hypoalbuminemia (8.3%). Cohort 2: most common all-grade AEs were nausea (44.4%), diarrhea (22.2%), leukopenia (22.2%); only Grade ≥3 diarrhea (11.1%) was severe. No unexpected serious AEs (SAEs) occurred in either cohort. Conclusions: This study initially confirms that liposomal irinotecan combined with oxaliplatin + 5-FU/LV ± camrelizumab as preoperative chemotherapy for BRPC effectively controls tumor progression and improves R0 resection rate with good safety, providing a potential preoperative chemotherapy option for BRPC patients. Clinical trial information: NCT06345300 .