NCT07161453尚未招募4 期
A Multicenter, Prospective, Real-world Study Comparing the Efficacy and Safety of Different Postoperative Adjuvant Regimens in Patients With Resectable Adenocarcinoma of the Esophagogastric Junction Who Underwent Radical Surgery After Neoadjuvant Chemotherapy Combined With Immunotherapy and Achieved pCR in Postoperative Pathology
Liaoning Cancer Hospital & Institute0 个研究点目标入组 500 人开始时间: 2025年9月30日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- Compare the differences in the DFS rates between the two groups of subjects, DFS (Disease-Free Survival, which is the time from the start of postoperative adjuvant therapy until the first occurrence of recurrent disease
研究概览
简要总结
This study is to evaluate the efficacy and safety of different postoperative adjuvant regimens in patients with resectable adenocarcinoma of the esophagogastric junction who underwent radical surgery after neoadjuvant chemotherapy combined with immunotherapy and achieved pCR in postoperative pathology
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, gender not restricted;
- •Subjects diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJC) through imaging and other examinations, and with histopathological diagnosis of adenocarcinoma;
- •HER2 overexpression or amplification results are negative;
- •Subjects who have received neoadjuvant chemotherapy for GC/GEJC before, and have undergone at least 3-4 cycles;
- •Having undergone radical surgical treatment and with postoperative pathological result reaching pCR
- •After radical surgery treatment, the investigator assesses that further adjuvant treatment is necessary, and the adjuvant treatment plan must be the one specified in this protocol.
排除标准
- •1) Gastric cancer that is known to be squamous cell carcinoma, undifferentiated carcinoma, or of other tissue types, or gastric cancer that is adenocarcinoma mixed with other tissue types; 2) Within 3 months before adjuvant therapy, there was a significant clinically significant bleeding symptom or a clear bleeding tendency; 3) Within 6 months before adjuvant therapy, had suffered from intestinal obstruction and/or had clinical signs or symptoms of digestive tract obstruction, including incomplete obstruction related to the original disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding; 4) Within 5 years before starting adjuvant therapy, was diagnosed with a malignant tumor (excluding malignant tumors with low metastasis and mortality risks, such as: skin basal cell carcinoma or cervical carcinoma in situ that has been adequately treated); 5) Within 30 days before starting adjuvant therapy, had participated in other clinical studies and used study drugs containing active ingredients;
研究组 & 干预措施
SOX or XELOX with immunotherapy
Experimental
干预措施: SOX plus PD-1 inhibitor (Drug)
Immunotherapy
Experimental
干预措施: PD-1 / PD-L1 monoclonal antibody (Drug)
SOX or XELOX
Active Comparator
干预措施: SOX Chemotherapy (Drug)
Tegafur-Ugotex or Capecitabine
Active Comparator
干预措施: Tegafur-Ugotex or Capecitabine (Drug)
结局指标
主要结局
Compare the differences in the DFS rates between the two groups of subjects, DFS (Disease-Free Survival, which is the time from the start of postoperative adjuvant therapy until the first occurrence of recurrent disease
时间窗: The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 years
次要结局
- Compare the differences in the OS rates between the two groups of subjects, OS (Overall Survival, which refers to the time from the start of postoperative adjuvant therapy until death due to any cause)(The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 years)
- The Adverse Events of anti-PD1/PDL1 monoclonal antibody combined with chemotherapy versus chemotherapy in postoperative adjuvant treatment for gastric cancer/adenocarcinoma of the esophagogastric junction(The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 years)
研究者
Zhao Yan
Deputy Director
Liaoning Cancer Hospital & Institute
相似试验
招募中
不适用
Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced UTUCUreter CancerAdvanced Urothelial CarcinomaRenal Pelvic CarcinomaNCT0659876160
Enrolling By Invitation
不适用
A Multicenter Prospective Cohort Study of Adjuvant Therapy for BRCA1/2 Mutated Hormone Receptor-positive HER2-negative Early High-risk Breast CancerNCT06791161Cancer Institute and Hospital, Chinese Academy of Medical Sciences300
已完成
3 期
Study of Adjuvant ONO-4538 With Resected Gastric CancerGastric CancerNCT03006705Ono Pharmaceutical Co. Ltd800
招募中
2 期
Adjuvant Treatment Based on MRD for EGFR Mutant NSCLCMRDNCT05536505Guangdong Association of Clinical Trials180
招募中
3 期
Study of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ AdenocarcinomaGastric CancerNCT04997837Fudan University433