A prospective single-arm study of irinotecan liposome II combined with adebrelimab, gemcitabine, and nab-paclitaxel for conversion therapy in locally advanced pancreatic cancer.

TPS4265 Background: Locally advanced pancreatic cancer (LAPC) has an extremely poor prognosis, with only a minority of patients eligible for radical surgery at initial presentation. Conversion therapy is critical for improving resectability and survival. Currently, no standard conversion regimen exists for LAPC, and gemcitabine plus nab-paclitaxel (AG regimen) is widely used. Irinotecan liposome has favorable tumor targeting and manageable toxicity; the PAN-HEROIC-1 study showed that irinotecan liposome II combined with 5-fluorouracil/leucovorin (5-FU/LV) significantly prolonged overall survival in Chinese advanced pancreatic cancer patients. Adebelimab, a programmed death-ligand 1 (PD-L1) inhibitor, exerts synergistic antitumor effects with chemotherapy in solid tumors. Herein, we evaluate the efficacy and safety of Irinotecan Liposome II plus Adebelimab and AG regimen as conversion therapy for LAPC to improve surgical conversion rates and survival benefits. Methods: This prospective, single-arm, open-label study plans to enroll 45 patients with pathologically confirmed locally advanced pancreatic ductal adenocarcinoma. Key inclusion criteria: 18-75 years old; Eastern Cooperative Oncology Group (ECOG) PS 0-1; adequate major organ function; no central nervous system metastasis; effective contraception for reproductive-aged subjects (pregnancy excluded); informed consent. Exclusion criteria: non-ductal pancreatic cancer; active autoimmune diseases; severe infections; major surgery or investigational drugs within 4 weeks prior to enrollment; other investigator-judged ineligibility. Primary endpoint is surgical conversion rate; secondary endpoints include event-free survival, overall survival, R0/R1 resection rate, objective response rate, pathological complete response rate, and safety profile. Treatment Regimen: Irinotecan Liposome II (40 mg/m², IV infusion 90±30 min, Day 1, q2w) + Adebelimab (1200 mg, IV infusion 30-60 min, Day 1, q4w) + gemcitabine (1000 mg/m², IV infusion > 30 min, Days 1,8,15, q4w) + nab-paclitaxel (125 mg/m², IV infusion > 30 min, Days 1,8,15, q4w). Registration Number: ChiCTR 2500108269. Research Sponsor: Hengrui Pharma. Clinical trial information: ChiCTR2500108269.