Multi-center phase II study of nab-paclitaxel plus camrelizumab versus nab-paclitaxel alone as second-line treatment for advanced gastric cancer.

[BACKGROUND] Nab-paclitaxel is a standard second-line treatment for advanced gastric cancer, but the role of PD-1 inhibitors remains uncertain. This multicenter, randomized phase II trial evaluated the efficacy of nab-paclitaxel plus camrelizumab (Cam-NP) versus nab-paclitaxel alone (NP) in patients with advanced gastric adenocarcinoma resistant to prior treatment.

[METHODS] Patients were randomized to receive either Cam-NP or NP until disease progression, intolerable toxicity, or consent withdrawal. The primary endpoint was the overall response rate (ORR), with secondary endpoints including progression-free survival (PFS), overall survival (OS), and safety.

[RESULTS] Sixty one patients were randomized, with 58 receiving treatments. At a median follow-up of 34.5 months, the Cam-NP group achieved a significantly higher ORR (33.3% vs. 10.7%; P = .039) and longer median PFS (5.62 vs. 4.21 months; P = .006). Median response duration also favored Cam-NP (4.64 vs. 2.96 months; P = .058). While the Cam-NP group showed a longer OS (9.8 vs. 7.2 months; P = .087), this was not statistically significant. The most common grade 3-4 adverse event was hematological toxicity.

[CONCLUSIONS] Cam-NP significantly improved ORR and PFS compared to NP as a second-line treatment for advanced gastric adenocarcinoma. Larger studies and biomarker exploration are needed to validate these findings.

[TRIAL REGISTRATION] ClinicalTrials.gov, NCT04294784, 03/02/2020.