A phase 2 trial presented at the 2025 ASCO Gastrointestinal Cancer Symposium revealed that camrelizumab in combination with nab-paclitaxel, oxaliplatin, and fluorouracil (Nab-POF) yields promising outcomes for patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. The FDZL-001 trial (NCT04510064) demonstrated safe conversion rates and high efficacy responses after 3 years of follow-up, suggesting a potential new treatment avenue for this challenging cancer.
The study enrolled 52 patients with initially unresectable, locally advanced, or limited metastatic gastric or GEJ adenocarcinoma. The primary endpoint was R0 resection rate, while secondary endpoints included overall response rate (ORR), disease control rate (DCR), pathological complete response (pCR), total complete response (CR), progression-free survival (PFS), and overall survival (OS).
Efficacy Outcomes
The R0 resection rate, the proportion of patients achieving complete tumor removal with no residual cancer cells at the margins, was 75.0%. A pathological complete response (pCR) was observed in 23.1% of patients, indicating the absence of viable cancer cells in the resected specimen. The overall response rate (ORR) was 88.5%, and the disease control rate (DCR) reached 98.1%. The total complete response rate (CR), encompassing both clinical and pathological complete responses, was 23.1%.
The median overall survival (OS) was not reached (95% CI, 25.4-NE), with a 3-year OS rate of 62.8% (95% CI, 41.6%-78.0%). The median progression-free survival (PFS) was also not reached (95% CI, 17.0-NE), and the 3-year PFS rate was 56.9% (95% CI, 45.7%-86.3%).
Safety Profile
Treatment-related adverse events (TRAEs) were observed in all patients, with 42.3% experiencing grade 3/4 events. The most common hematologic TRAEs included anemia (86.5% all grade vs 3.8% grade 3/4), neutropenia (78.8% vs 36.5%), leukopenia (63.5% vs 9.6%), and thrombocytopenia (48.1% vs 3.8%). Non-hematologic TRAEs included reactive cutaneous capillary endothelial proliferation (63.5% vs 0.0%), aspartate aminotransferase increase (51.9% vs 1.9%), alanine aminotransferase increase (50.0% vs 1.9%), and rash (21.1% vs 1.9%). Immune-related adverse events of any grade occurred in 19.2% of patients, with 3.8% experiencing grade 3/4 events.
Expert Commentary
According to Dr. Qirong Geng from the Department of Medical Oncology, Fudan University Shanghai Cancer Center, the FDZL-001 trial "preliminarily shows promising results providing a new conversion drug treatment option for patients with initially unresectable, locally advanced and limited metastatic gastric or GEJ adenocarcinoma."
