Comparing the Efficacy and Safety of Chemotherapy Combined With or Without Immunotherapy as an Adjuvant Treatment After Radical Surgery for Patients With Resectable Adenocarcinoma of the Esophagogastric Junction of Gastric Cancer

Not Applicable

Not yet recruiting

• Conditions: Gastric / Gastroesophageal Junction Adenocarcinoma
• Interventions: Drug: SOX plus PD-1 inhibitor; Drug: SOX Chemotherapy

• Registration Number: NCT07132528
• Lead Sponsor: Liaoning Cancer Hospital & Institute

Brief Summary

This study is to evaluate the efficacy and safety of chemotherapy combined with or without Immunotherapy as an Adjuvant Treatment After Radical Surgery for Patients With Resectable Adenocarcinoma of the Esophagogastric Junction of Gastric Cancer

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-10
• Study First Submitted QC: 2025-08-17
• Last Update Submitted: 2025-08-17
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Study Start: 2025-08-31
• Primary Completion: 2028-03-31
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Age ≥ 18 years old, gender not restricted;
2. Subjects diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJC) through imaging and other examinations, and with histopathological diagnosis of adenocarcinoma;
3. HER2 overexpression or amplification results are negative;
4. Subjects who have received neoadjuvant chemotherapy for GC/GEJC before, and have undergone at least 3-4 cycles;
5. 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.

Exclusion Criteria

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOX or XELOX with immunotherapy	SOX plus PD-1 inhibitor	-
SOX or XELOX	SOX Chemotherapy	-

Primary Outcome Measures

Name	Time	Method
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.	The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 years

Secondary Outcome Measures

Name	Time	Method
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