Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Gastric Cancer

Lin Chen80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Locally Advanced Gastric Carcinoma HER2 Negative Efficacy Safety

Tirolizumab+SOX/XELOXDRUG

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.

SOX/XELOXDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pathological complete response (pCR)

After neoadjuvant therapy, there were no residual surviving tumor cells in the tumor bed during the pathological remission assessment of postoperative specimens.