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);
Single group
Ipilimumab injection N01
DrugIpilimumab injection N01 (R\&D Code: IBI310) is a recombinant fully human anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody independently developed by Xinda Biotechnology (Suzhou) Co., Ltd. It can specifically bind to CTLA-4 molecule, thereby blocking CTLA-4-mediated T cell suppression, promoting T cell activation and proliferation, and enhancing tumor immune response. To achieve anti-tumor effect.
Sintilimab
DrugSintilimab is a recombinant fully human IgG4 PD-1 monoclonal antibody, which is a Class 1 new drug independently developed by Xinda Biotechnology (Suzhou) Co., Ltd. Sintilimab can specifically bind to PD-1 molecules on the surface of T lymphocytes, thereby blocking the PD-1/PD-L1 pathway leading to tumor immune tolerance. To reactivate the anti-tumor activity of T lymphocytes and achieve the purpose of tumor treatment.
Modified (60% standard dose) XELOX
DrugModified (60% standard dose) XELOX: (Oxaliplatin 78mg/m2,d1; capecitabine 600mg/m2,bid,d1-14,q3w)
Surgical conversion rate
Ratio of subjects who underwent surgical resection to all subjects who received a conversion therapy regimen
pCR rate
It was defined as the ratio of subjects with no viable tumor cells in the surgical resection specimen to all those who underwent surgery
MPR rate
It was defined as the proportion of subjects with ≤10% viable tumor cells in the surgically resected specimen among all patients who underwent surgery
ORR
It was defined as the ratio of complete remission (CR) and partial remission (PR) among the total subjects
AEs
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Chen Lizhu
Lead sponsor
Fujian Cancer Hospital
Sponsor institution
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