To evaluate the efficacy and safety of adebrelimab combined DOS in neoadjuvant treatment of locally advanced resectable gastric cancer.
This prospective, single-center, single-arm clinical trial aims to enroll 42 treatment-naïve patients diagnosed with locally advanced gastric adenocarcinoma who are deemed operable. Following informed consent, patients will undergo screening to confirm eligibility. Subsequently, eligible participants will receive the standard dosage of Adebrelimab in combination with the DOS regimen for three cycles as neoadjuvant therapy prior to surgery. Within 3-6 weeks after completing the third cycle, preoperative imaging will be conducted to assess the efficacy of the novel neoadjuvant treatment and feasibility of achieving radical D2 resection. Patients will then undergo radical surgical resection for gastric cancer, with pathological complete response (pCR) being observed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
After signing the informed consent, they are screened to meet the inclusion criteria. After receiving the standard dose of adebrelimab combined with DOS regimen for 3 courses of treatment before surgery, and within 3-6 weeks after the completion of the third administration, preoperative imaging examination is used to evaluate the efficacy of new adjuvant treatment and the possibility of radical D2 resection, The patient underwent radical surgical treatment for gastric cancer and observed pCR
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shannxi, China
RECRUITINGPathological complete response rate(pCR)
Pathological complete response rate according to Becker standard
Time frame: 7 days after surgery
Major pathologic response (MPR)
MPR is defined as less than 10% residual viable tumor after neoadjuvant therapy.
Time frame: 7 days after surgery
Disease-free survival(DFS)
The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer
Time frame: Long term follow-up will continue until the death of the subject or the end of the study, at least three years
R0 resection rate
Proportion of R0 level surgery performed.
Time frame: postoperative 6 hours
Overall Survival(OS)
Overall survival (OS) refers to the time that researchers evaluate from recording the first chemotherapy to death (of any cause).
Time frame: Long term follow-up will continue until the death of the subject or the end of the study, at least three years
Objective response rate(ORR)
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response.
Time frame: 7 days before surgery
Event-free survival(EFS)
The length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay.
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Time frame: Preoperative progression, postoperative recurrence, and death from any cause
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Adverse reactions to chemotherapy and immunotherapy were graded according to the NCI-CTCAE4.0 grading criteria
Time frame: Long term follow-up will continue until the death of the subject or the end of the study, at least three years