Efficacy, HER2 Negative, Locally Advanced Gastric Carcinoma, Safety
Conditions
Brief summary
This study objectively analyzes the safety and survival evaluation of perioperative immunotherapy combined with chemotherapy in locally advanced gastric cancer patients through a prospective randomized controlled trial research method; By comparing the pathological response rate, disease-free survival rate, and incidence of adverse events between the combination therapy and chemotherapy alone group, we aim to verify the efficacy and safety of tirelizumab combined with SOX/XELOX chemotherapy in disease control of locally advanced gastric cancer patients, laying the foundation and providing a basis for large-scale multicenter clinical research.
Interventions
DRUGTirolizumab+SOX/XELOX
Tirolizumab combined with chemotherapy(SOX/XELOX) regimen. The SOX regimen consists of the drugs Tegilol (S-1) and Oxaliplatin. The XELOX regimen consists of the drugs oxaliplatin and capecitabine.
DRUGSOX/XELOX
Simple chemotherapy regimen (SOX/XELOX regimen). The SOX regimen consists of the drugs Tegilol (S-1) and Oxaliplatin. The XELOX regimen consists of the drugs oxaliplatin and capecitabine.
Sponsors
Lin Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The subjects voluntarily joined this study and signed an informed consent form * Locally advanced gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or histology as HER-2 negative (cT2-4N+M0 Phase II-III) * The primary lesion can be surgically removed, and the patient is willing to receive surgical treatment * There are measurable solid tumors (efficacy evaluation standard: RECIST 1.1) * Tumor evaluation should be conducted through CT scanning or MRI within 28 days before treatment * ECOG score 0-1 * Life expectancy ≥ 12 months.
Exclusion criteria
* Preoperative imaging examination indicates distant or peritoneal metastasis in patients * Subjects with any known active autoimmune disease * Serious cardiovascular disease * The serum of the subjects tested positive for HIV * Active hepatitis B (HbsAg positive and HBV-DNA ≥ 10 \^ 3copies/mL) or active hepatitis C (HCV antibody positive and HCV-DNA positive, requiring antiviral treatment at the same time) * Known subjects with previous allergies to macromolecular protein formulations/monoclonal antibody components, or other contraindications to immunotherapy or chemotherapy * Have a history of alcohol, drug, or substance abuse * Individuals with a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response (pCR) | Less than 20 months | After neoadjuvant therapy, there were no residual surviving tumor cells in the tumor bed during the pathological remission assessment of postoperative specimens. |
| Objective Response Rate（ORR） | Less than 20 months | The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit requirement is the sum of complete response (CR) and partial response (PR) ratios, with ORR=CR+PR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival（DFS） | Less than 20 months | Time from randomization to disease recurrence or (for any reason) death. |
| Overall survival（OS） | Less than 20 months | Time from randomization to death (for any reason) |
| Major Pathologic Response（MPR） | Less than 20 months | After preoperative treatment, the number of surviving tumors decreases below the threshold that can affect clinical prognosis. |
| The incidence of adverse events during treatment | Less than 20 months | Including adverse reactions related to immunotherapy and postoperative complications. Reflecting safety and tolerability. |
Countries
China
Outcome results
None listed