Abstract CT167: Phase II study of Nimotuzumab combined with AG regimen in pancreatic cancer with liver metastases (PCLM): A prospective, single-arm trial

Abstract Background: Patients with PCLM represent approximately 70% of advanced pancreatic cancer cases in our department and often have limited surgical options due to the aggressive nature of their tumors. For patients with good performance status (ECOG PS 0-1), the NCCN guidelines recommend Gemcitabine plus Nab-paclitaxel (AG). While Nimotuzumab combined with Gemcitabine has shown survival benefits, there is limited clinical data on its efficacy when combined with AG for treating PCLM. This study aims to evaluate the safety and efficacy of adding Nimotuzumab to the AG regimen for PCLM. Methods: Patients with potentially resectable, treatment-naïve PCLM received Nimotuzumab (400 mg, iv, d1, qw) and AG chemotherapy (Gemcitabine 1000mg/m2, Nab-paclitaxel 125mg/m2, d1, d8, 21d cycle). After two cycles of treatment, patients eligible for surgery underwent resection, while others continued treatment until disease progression, unacceptable toxicity, or withdrawal. The primary endpoints were objective response rate (ORR) and disease control rate (DCR), with secondary endpoints including surgical conversion rate, R0 resection rate, pathological complete response (pCR) rate and adverse events (AEs). Results: As of October 29, 2024, data were collected from 26 PCLM patients. The median duration of Nimotuzumab treatment was 4 months (range: 1-13), with a median follow-up of 10 months. The average age was 62 years (range: 40-75), and 73.1% of patients were male, all with an ECOG PS of 0-1. In 22 patients with initial efficacy assessments, the ORR was 13.6% (3/22), and the DCR was 77.3% (3 PR, 14 SD). The CA19-9 response rate, with a >50% drop from baseline, was 54.5% (12/22). After 2-5 months of conversion therapy, 10 patients underwent surgery, resulting in a surgical resection rate of 45.5%, with no patients achieving pCR. The median progression-free survival (PFS) was 5 months, and median overall survival (OS) has not yet been reached. The most common adverse events were nausea and vomiting, which were resolved or improved with symptomatic treatment. No grade 4-5 TRAEs were observed. Conclusions: Combining Nimotuzumab with AG therapy can facilitate conversion to surgical resection in patients with PCLM, while maintaining a manageable safety profile. Clinical trial: NCT06405685. Citation Format: Dandan Wu, Yang Liu, Linlin Fu, Yinchao Zhang, Linze Xu, Jin Zhang, Huikai Li, Jihui Hao. Phase II study of Nimotuzumab combined with AG regimen in pancreatic cancer with liver metastases (PCLM): A prospective, single-arm trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT167.