Efficacy and Safety of ramucirumab Combined With Nab‐paclitaxel, Lobaplatin, and S‐1 in Conversion Therapy for Unresectable Advanced Gastric Cancer: Preliminary Results of Conversion Therapy Cohort of RNPLS‐01 Trial

This single‐center randomized controlled trial assessed the efficacy and safety of the ramucirumab plus nab‐paclitaxel, lobaplatin, and S‐1(RNPLS) regimen for conversion therapy in unresectable advanced gastric cancer. Seventy patients were equally assigned to receive either ramucirumab, nab‐paclitaxel, lobaplatin, and S‐1(RNPLS) therapy or nab‐paclitaxel, lobaplatin, and S‐1(NPLS) chemotherapy alone. Primary endpoints included pathological complete response (pCR) and secondary endpoints encompassed R0 resection rate, objective response rate (ORR), the disease control rate (DCR), progression‐free survival (PFS), overall survival (OS), duration of response (DOR), and adverse events (AE). Although the difference in pCR rate was statistically insignificant between the two groups, the RNPLS group achieved significantly higher ORR, DCR, and R0 resection rate. Moreover, the RNPLS regimen yielded prolonged PFS, longer duration of response, and promising preliminary OS. While hypertension occurred more frequently in the RNPLS group, the incidence of grade ≥3 AEs was low and comparable in both cohorts. This exploratory single‐center randomized trial showed preliminary favorable efficacy of RNPLS regimen for conversion therapy in unresectable advanced gastric cancer with manageable toxicity.

Trial Registration

ClinicalTrials.gov: NCT06169410