Comparing the Efficacy and Safety of Chemotherapy Combined With or Without Immunotherapy as Postoperative Adjuvant Regimens in Patients With Resectable Gastric Cancer/Adenocarcinoma of the Esophagogastric Junction After Radical Surgery
NCT ID: NCT07149181
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE4
1000 participants
INTERVENTIONAL
2025-08-31
2028-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SOX or XELOX with immunotherapy
SOX plus PD-1 inhibitor
SOX or XELOX plus PD-1 inhibitor
SOX or XELOX
SOX Chemotherapy
SOX or XELOX
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SOX plus PD-1 inhibitor
SOX or XELOX plus PD-1 inhibitor
SOX Chemotherapy
SOX or XELOX
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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. 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
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;
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Liaoning Cancer Hospital & Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zheng Guoliang
Vice Offices Director
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KY20250315
Identifier Type: OTHER
Identifier Source: secondary_id
NeoGC-03
Identifier Type: -
Identifier Source: org_study_id