Camrelizumab Combined with Gemcitabine and Albumin-Bound Paclitaxel in Pancreatic Cancer Patients with Liver Metastases: A Prospective, Pilot Trial.

[BACKGROUND] Pancreatic ductal adenocarcinoma (PDAC) is one of the most malignant tumors, with approximately 80% of PDAC patients having locally advanced or metastatic disease at diagnosis. The liver is a predominant site of metastasis and is linked to a particularly poor prognosis. Here, we explored camrelizumab (an anti-programmed cell death-1 antibody) combined with albumin-bound paclitaxel and gemcitabine (AG) in patients with PDAC and liver metastases (PCLM).

[METHODS] In this pilot trial (ChiCTR2000038587), patients received camrelizumab (200 mg on day 1) plus gemcitabine (1000 mg/m on days 1 and 8) and albumin-bound paclitaxel (125 mg/m on days 1 and 8) every 21-day cycle until disease progression, intolerable toxicity, or death. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety. Exploratory analyses evaluated potential biomarkers associated with survival.

[RESULTS] From October 2018 to October 2023, 17 patients were enrolled. The median OS was 14.0 months (95% confidence interval [CI], 10.0-24.0) and the median PFS was 6.4 months (95% CI, 5.2-10.2). Five patients achieved an objective response (29.4%), with a DCR of 64.7%. Fewer liver metastasis lesions, higher white blood cell-to-lymphocyte ratio, and lower neutrophil-to-lymphocyte ratio were associated with improved PFS and OS (P<0.05). Grade 3 treatment-related adverse events (TRAEs) included platelet count decreased (2 [11.8%]) and neutrophil count decreased (1 [5.9%]). No grade 4 or 5 TRAEs occurred.

[CONCLUSION] Camrelizumab combined with AG demonstrates promising antitumor activity in patients with PCLM, with an acceptable safety profile.