Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Focusing on the clinical question of whether patients with advanced gastric cancer can benefit from immunotherapy, this project intends to detect the degree of CD8+ tumor-infiltrating lymphocyte infiltration in patients with advanced gastric cancer before and after receiving neoadjuvant combined immunotherapy and neoadjuvant therapy alone. To explore the evolving nature of tumor immune response before and after neoadjuvant therapy for gastric cancer, and quantitatively present it through chemical immunohistochemical techniques to achieve a more accurate diagnosis and treatment and improve the long-term efficacy of patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radical surgery after neoadjuvant immunotherapy (albumin Paclitaxel + Seggio + PD-1 inhibitor) | Experimental | After randomization, patients received radical surgery after the neoadjuvant immunotherapy (albumin Paclitaxel + Seggio + PD-1 inhibitor) |
|
| radical surgery after neoadjuvant chemotherapy (albumin Paclitaxel + Seggio) | Active Comparator | After randomization, patients received radical surgery after neoadjuvant chemotherapy (albumin Paclitaxel + Seggio) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radical surgery after neoadjuvant immunotherapy | Combination Product | A total or distal gastrectomy with D2 lymph node dissection was done depending on the tumor location after neoadjuvant immunotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of CD8+ tumor-infiltrating lymphocytes in tumor tissue and adjacent tissue before and after treatment | Changes in the number of CD8+ tumor-infiltrating lymphocytes in the tumor and adjacent tissues of the experimental group before and after the surgery compared with the control group. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Complete response (CR) + partial response (PR) | 6 months |
| Disease-free survival (DFS) | Time from study entry to disease recurrence or patient death due to disease progression |
Not provided
Inclusion Criteria:
(1) Blood routine examination should meet the requirements (no blood transfusion within 14 days):
a. BIL <1.5×upper limit of normal (ULN), b. ALT and AST<2.5ULN,GPT≤1.5×ULN; c. Cr≤1ULN,Ccr >60ml/min 9. Fertile women must have taken a pregnancy test (serum) within 7 days prior to enrollment with negative results and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last trial drug; For men, they should be surgically sterilized or agree to use the appropriate method of contraception during the trial period and 8 weeks after the last administration of the trial drug 10. Did not participate in other clinical studies before and during treatment 11. Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| radical surgery after neoadjuvant chemotherapy | Combination Product | A total or distal gastrectomy with D2 lymph node dissection was done depending on the tumor location after neoadjuvant immunotherapy. |
|
| 2 years |
| Overall survival (OS) | Time from study entry to death from any cause. | 2 years |
| Therapeutic drug safety | Adverse events (AEs), serious adverse events (SAEs), drug-related AEs, SAEs, and class-specific AEs (eg, hypertension, proteinuria, and hand-foot syndrome) | 6 months |
| Surgical safety | R0 resection rate, operative mortality, surgical complications (bleeding, anastomotic leakage, incision infection), reoperation rate, hospital stay, etc. | 6 months |