Efficacy and safety of nimotuzumab plus AG regimen as conversion therapy for locally advanced pancreatic cancer: A prospective, single-arm study.

Abstract

e16451 Background: Conversion therapy for locally advanced pancreatic cancer (LAPC) remains a challenging area, with the median overall survival of existing regimens less than 1 year. Patients with a significant response to chemotherapy may be considered for surgical resection. Following resection, these patients have similar survival rates as those initially determined to be resectable. But conversions are rare in patients with true locally advanced disease. Nimotuzumab has shown potential in pancreatic cancer treatment and previous studies have confirmed its chemosensitization effect when combined with gemcitabine or paclitaxel. This study aimed to evaluate the efficacy and safety of nimotuzumab combined with the AG regimen as conversion therapy for LAPC. Methods: This is an open-label, single-arm, and single-center phase II trial. Patients with pathologically and radiographically confirmed LAPC without prior anti-cancer treatment or severe morbidities were enrolled. All patients received Nimotuzumab (400mg per week) plus AG regimen (gemcitabine 1,000 mg/m 2 and nab-paclitaxel 125 mg/m 2 on days 1 and 8, every 3 weeks) as conversion therapy, and imaging assessments (according to RECIST V.1.1 criteria) were performed every two months of conversion therapy. The primary endpoint was R0 resection rate. Additional end points included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), tumor regression grade (TRG), pain relief rate and safety, etc. Results: Fifteen patients were enrolled at West China Hospital from September 2023 to January 2025. Median age was 60.38 (43-77) years, 73.3% were male and head of pancreas lesions were most common (53.3%). During the conversion treatment period, 53.3% (8/15) had a TRG score of 0-2 and 81.8% achieved pain relief. Among 14 evaluable patients, ORR was 21.4%, and DCR was 92.9%. Ten patients (66.7%) achieved conversion resection (all R0 resections) after a median of 3.5 months of treatment. As of January 25, 2025, with a median follow-up time of 8.21 months (95% confidence interval [CI], 3.64 - 12.78), survival analysis showed that the median PFS was 12.45 months (95% CI, 7.58 - 17.33) and the median OS was not reached. Regarding safety, 7 patients (46.7%) experienced adverse events (with 16 occurrences), most of which were grade 1-2. All adverse events were cured or effectively controlled after symptomatic treatment. Conclusions: Nimotuzumab combined with the AG regimen demonstrated certain efficacy and acceptable safety as conversion therapy for LAPC. Our interim analysis showed a significant effect of conversion surgery, which may be relevant to clinical practice, providing a potential option for this group of patients. However, further studies with larger samples are needed. Clinical trial information: ChiCTR2400084464 .