This Phase II clinical study is a prospective, open-label, single-arm trial designed to evaluate the efficacy and safety of combining anti-PD-1 therapy (Serplulimab) with thymalfasin and the SOX chemotherapy regimen as a neoadjuvant treatment for patients with clinical stage III gastric or gastroesophageal junction(GEJ) adenocarcinoma.
This is a prospective, open-label, single-arm phase II clinical study to assess the efficacy and safety of Serplulimab in combination with thymalfasin and SOX regimen for neoadjuvant therapy of locally advanced gastric cancer. It is planned to enroll 30 patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology and/or cytology who were clinically staged as stage III resectable G/GEJ carcinoma as assessed by endoscopic ultrasonography, CT/MRI and other imaging. The primary endpoint of the study was pathological complete response (pCR) rate. The secondary end points included major pathological response(MPR) rate, Tumor Regression Grade (TRG), Clinical downstaging rate (T and/or N downstaging), Objective Response Rate (ORR), Disease Control Rate (DCR), R0 resection rate, Disease-free Survival (DFS), Overall Survival (OS) and treatment-related adverse events (TRAEs).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
200 mg, i.v., D1, Q3W
4.8mg,sc,biw
130 mg/m2, i.v., D1, Q3W
The First Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGpathological Complete Response (pCR)
pCR was defined as no residual tumor cells on the histologic examination of surgical specimens.
Time frame: from preoperative to 10 days postoperative
Major Pathological Response (MPR)
For patients with surgically resectable gastric cancer after neoadjuvant therapy, the proportion of patients with less than 10% residual tumor cells in the primary site.
Time frame: from preoperative to 10 days postoperative
Tumor Regression Grade (TRG)
It is intended to grade the pathological response of tumor after neoadjuvant therapy and generally divide the grade mainly according to the proportion of fibrosis and residual tumor in the tumor. In this study, Becker criteria are used to grade TGR as follows: TRG1a (no residual tumor), equivalent to pCR; TRG1b (\< 10% residual tumor); TRG2 (10% to 50% residual tumor); and TRG3 (\> 50% residual tumor).
Time frame: from preoperative to 10 days postoperative
Clinical downstaging rate (T and/or N downstaging)
ypT0 ratio, ypN0 ratio, and preoperative imaging clinical stage will be counted, respectively, to compare with baseline imaging clinical stage downstaging ratio
Time frame: before surgery
Objective Response Rate (ORR)
It refers to the proportion of patients whose tumor shrinks to a certain extent and remains for a certain period of time, including CR (Complete Response) and PR (Partial Response) cases. Objective tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria).
Time frame: before surgery
Disease Control Rate (DCR)
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oral administration: body surface area \< 1.25, 40 mg each time; body surface area ≥ 1.25 to \< 1.5, 50 mg each time; body surface area ≥ 1.5, 60 mg each time, twice daily for each treatment cycle at D1-D14
It refers to the percentage of confirmed complete response (CR), partial response (PR) and stable disease (SD) cases among evaluable efficacy patients.
Time frame: before surgery
Disease-free Survival (DFS)
Disease-free survival refers to the time from the start of randomization to disease recurrence or death due to disease progression. DFS will be defined as the last date the patient is last confirmed to be disease-free survival if the patient does not experience disease progression during the study.
Time frame: 2 years after surgery
Overall Survival (OS)
Overall survival refers to the date from enrollment to death due to any cause.
Time frame: 2 years after surgery
R0 resection rate
R0 resection rate refers to the proportion of patients who complete R0 resection in surgically resectable patients after neoadjuvant therapy.
Time frame: from preoperative to 10 days postoperative
treatment-related adverse event (TRAE)
incidence of treatment-related adverse event
Time frame: from the start of neoadjuvant therapy to 30 days after surgery