This study is a single-arm, prospective, phase II clinical trial. The patients are diagnosed with resectable locally advanced (cT3-4N+M0) gastric adenocarcinoma and esophageal gastric adenocarcinoma that had not been treated before.
After signing the informed consent form, patients will be screened for the study treatment of Adebrelimab combined with AOS. After 2 cycles of treatment, MDT assessments before surgery will be carried out. Patients with no disease progression will receive one more cycle of treatment before surgery. For patients who have undergone radical surgery, they will continue to receive 3 cycles of the immunochemotherapy after the operation (a total of 6 cycles of combined treatment before and after surgery), followed by Adebrelimab single treatment for up to a year (16 cycles).
Patients whose disease progressed that can not be surgically removed after preoperative treatment will be treated by the oncology physicians according to clinical routines.
Patients voluntarily participate in this study and sign informed consent forms;
18-75 years old;
Patients whose tumor has been pathologically diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, and has not received any type of antitumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);
Confirmed TNM staging by CT or MRI as resectable cT3-4N+M0;
Patients who are known to have peritoneal metastasis or positive peritoneal lavage cytology (CY1P0) or have distant metastasis;
Patients whose tumor can not be resected by surgery for tumor reasons or comorbidity or patients who refuse to undergo surgery;
Patients who have other malignant tumors within the past 5 years or at the same time, except for cured skin basal cell carcinoma, cervical in situ and breast cancer in situ;
The toxicity of previous anti-tumor treatment has not recovered to CTCAE≤grade one (NCI CTCAEv5.0), except for hair loss (any level allowed) and peripheral neuropathy (need to be ≤grade two );
Single group
Adebrelimab, Nab-paclitaxel, Oxaliplatin, Tegafur Gimeracil Oteracil Potassium Capsule
DrugAdebrelimab combined with Nab-paclitaxel, Oxaliplatin andTegafur Gimeracil Oteracil Potassium Capsule
pathological complete response rate (pCR)
The percentage of patients who undergone surgery with tumor regression grade of class one, which there is no tumor cell residue in the tumor lesions.
Event Free Survival (EFS)
From the beginning of the study treatment to the first occurrence of any of the following events: disease progression, local or distant recurrence and metastasis, death, etc.
major pathological response rate (MPR)
The percentage of patients with TRG grade two, which the tumor residues are rare in tumor lesions.
Treatment safety
The adverse events occur during the study treatment, including that occurs during the immunochemotherapy and the surgery.
biomarker
PD-L1, TMB, ctDNA, plasma cytokine, plasma proteome
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