This study was a prospective, single-arm, multi-center, phase Ⅱ clinical study to investigate the efficacy and safety of ipilimumab injection N01 combined with sintilimab and modified XELOX conversion therapy in patients with unresectable locally advanced gastric cancer who had not received systemic treatment.
Provided written informed consent before performing any trial-related procedures;
Age ≥18 years old and ≤80 years old, regardless of gender;
Histologically confirmed gastric or gastroesophageal junction adenocarcinoma, PDL1 CPS≥1, and unresectable locally advanced gastric cancer confirmed by MDT or investigator assessment (based on imaging and EUS assessment). Conclusions: The main reasons for unresectable locally advanced gastric cancer at initial diagnosis include: severe invasion of the primary tumor, inability to separate from surrounding organs or wrap around important blood vessels, or metastasis and fixation of regional lymph nodes, and inability to achieve R0 resection according to MDT discussion or investigator evaluation. R0 resection was considered unresectable if a Whipple's operation was performed in conjunction with it.
At least one radiographic measurable lesion according to response evaluation Criteria in Solid Tumors (RECIST, version 1.1);
Known HER2 positivity;
Malignant diseases other than gastric cancer (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection in situ carcinoma) diagnosed within 5 years before the first dose;
Are currently participating in an interventional clinical study treatment, or have received another study drug or investigational device within 4 weeks before the first dose;
Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent targeting another T-cell receptor that stimulates or coinhibits it (e.g., CTLA-4, OX-40, CD137);
Chen Lizhu
Lead sponsor
Fujian Cancer Hospital
Sponsor institution