The goal of this clinical trial is to evaluate postoperative adaptive adjuvant therapy in patients with gastric or gastroesophageal junction adenocarcinoma after neoadjuvant chemotherapy plus immunotherapy and radical gastrectomy.The main questions it aims to answer are:
1. In patients with poor pathological response, does switching to a alternative postoperative treatment regimen improve survival? 2. In patients with complete pathological response, can observation without routine postoperative treatment maintain favorable survival outcomes? Participants will be assigned to different cohorts according to their pathological response after surgery and will be followed regularly for recurrence, survival, and treatment-related side effects.
Voluntarily signed written informed consent.
Aged 18 to 75 years, inclusive, regardless of sex.
Underwent radical gastrectomy with D2 or more extended lymphadenectomy and achieved R0 resection. Surgical approaches may include open or laparoscopic surgery.
Histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma.
Presence of liver, peritoneal, or other distant metastases.
Inability to take oral medications.
Unresolved postoperative complications at the time of randomization, such as postoperative infection, anastomotic leakage or wound dehiscence, gastrointestinal bleeding, pancreatic fistula, or intestinal obstruction.
Uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically significant moderate or greater ascites at screening, defined as any of the following: pleural effusion or ascites with clinical symptoms and detectable by physical examination; or pleural effusion or ascites requiring drainage and/or intracavitary treatment during screening.
Parallel
Alternative Postoperative Treatment Regimen
DrugParticipants in this arm will switch to an alternative postoperative treatment regimen selected by the investigator according to prior neoadjuvant therapy, postoperative molecular subtype, and the 2025 CSCO and NCCN guidelines. The regimen will include taxane-based or irinotecan-based treatment that was not used before surgery, with dosage and administration based on clinical practice standards and drug prescribing information.
Original Treatment Regimen
DrugThe original preoperative treatment regimen will be continued postoperatively. The administration schedule and dosage of adjuvant therapy will follow standard clinical practice guidelines and the relevant drug prescribing information.
Postoperative Observation
Other interventionParticipants will undergo postoperative observation without further antitumor drug therapy. Routine follow-up monitoring will be conducted according to the study protocol.
Median Event-Free Survival in Cohort 1（mEFS）
defined as the time from randomization to the first documented local, regional, or distant recurrence, or death from any cause, whichever occurs first.
2-year Event-Free Survival Rate in Cohort 2（2-y EFS）
defined as the proportion of participants in Cohort 2 who are alive without documented local, regional, or distant recurrence at 2 years after cohort assignment.
1-year Event-Free Survival Rate in Cohort 1（1-y EFS）
defined as the proportion of participants in Cohort 1 who are alive without documented local, regional, or distant recurrence at 1 year after randomization.
1-Year Overall Survival Rate in Cohort 1（1-y OS）
defined as the proportion of participants in Cohort 1 who are alive at 1 year after randomization.
Median Overall Survival in Cohort 1（mOS）
defined as the time from randomization to death from any cause. Median overall survival will be evaluated in participants in Cohort 1.
2-Year Overall Survival Rate in Cohort 2（2-y OS）
defined as the proportion of participants in Cohort 2 who are alive at 2 years after cohort assignment.
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