Clinical Efficacy and Safety of Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Resectable Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Objective Response Rate（ORR）
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Tirelizumab combined with neoadjuvant chemotherapy
Four cycles of tirolizumab combined with SOX/XELOX neoadjuvant chemotherapy regimen before surgery, followed by laparoscopic D2 gastric cancer radical surgery, and four cycles of adjuvant chemotherapy after surgery.
干预措施: Tirolizumab+SOX/XELOX (Drug)
standard chemotherapy
Four cycles of standard chemotherapy regimen (SOX/XELOX regimen) were administered before and after surgery.
干预措施: SOX/XELOX (Drug)
结局指标
主要结局
Objective Response Rate（ORR）
时间窗: 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.
Pathological complete response (pCR)
时间窗: 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.
次要结局
- Overall survival（OS）(Less than 20 months)
- The incidence of adverse events during treatment(Less than 20 months)
- Disease-free survival（DFS）(Less than 20 months)
- Major Pathologic Response（MPR）(Less than 20 months)
研究者
Lin Chen
Attending physician
Chinese PLA General Hospital