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

Launched by LIN CHEN · Feb 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced gastric cancer that is HER-2 negative. Researchers want to find out if combining a drug called tirelizumab with standard chemotherapy (SOX/XELOX) can improve treatment outcomes compared to chemotherapy alone. They will look at how well the treatment works in shrinking tumors, how long patients remain free of disease, and any side effects that might occur.

To participate in this study, patients must be between the ages of 18 and 75, have been diagnosed with operable locally advanced gastric cancer, and agree to undergo surgery. They should also have a good overall health status, meaning they can carry out daily activities without significant limitations. Participants will receive the new treatment and will be closely monitored throughout the study. This trial is currently recruiting, and its findings could help shape future treatments for gastric cancer.

Gender

ALL

Eligibility criteria

• 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