Combining tirelizumab with chemotherapy for treating advanced gastric cancer
Clinical Efficacy and Safety of Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Resectable Gastric Cancer
This study is testing if combining a new immunotherapy called tirelizumab with chemotherapy can help people with advanced gastric cancer feel better compared to just chemotherapy alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, tirelizumab |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06284746 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of tirelizumab, an immunotherapy, combined with chemotherapy in patients with HER-2 negative locally advanced gastric cancer. It employs a prospective randomized controlled trial design to compare outcomes between patients receiving the combination therapy and those receiving chemotherapy alone. Key metrics for evaluation include pathological response rates, disease-free survival rates, and the incidence of adverse events. The goal is to establish a foundation for larger multicenter studies based on the findings.
Who should consider this trial
Good fit: Ideal candidates are patients with locally advanced HER-2 negative gastric or gastroesophageal junction adenocarcinoma who are eligible for surgical treatment.
Not a fit: Patients with distant metastasis or those with active autoimmune diseases or serious cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with advanced gastric cancer.
How similar studies have performed: While there have been studies exploring immunotherapy in gastric cancer, the specific combination of tirelizumab with SOX/XELOX chemotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing
- General Surgery Institute, China PLA General Hospital — Beijing, Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.