Status:
ACTIVE_NOT_RECRUITING
Using ctDNA to Guide Treatment Decisions for Stage III Gastric Cancer
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
First Affiliated Hospital of Suzhou Medical College
The Affiliated Hospital of Xuzhou Medical University
Conditions:
Gastric Cancer Stage III
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The goal of this randomized, controlled phase III clinical trial is to evaluate whether combining Tislelizumab with standard SOX chemotherapy improves disease-free survival (DFS) compared to chemother...
Eligibility Criteria
Inclusion
- Histological or Cytological Confirmation: Patients must have a confirmed diagnosis of stage III gastric or gastroesophageal junction adenocarcinoma (according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system) based on histological or cytological examination.
- Surgical Resection: Patients must have undergone D2 or more extensive lymph node dissection surgery, with available tumor tissue samples. Patients who received neoadjuvant therapy prior to surgery are excluded.
- Age: Patients must be between 18 and 75 years of age. General Condition: Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Informed Consent: Patients must be able to understand the study protocol and voluntarily participate in the study, providing written informed consent.
- Compliance: Patients must demonstrate good compliance, willingness to adhere to the treatment regimen specified in the study protocol, and ability to provide blood samples at designated time points.
- Clinical Data: Patients must have complete imaging and pathological clinical data available.
- Life Expectancy: Patients must have an expected survival of more than 3 months. Organ and Marrow Function: Patients must have adequate organ and bone marrow function.
Exclusion
- Inability to Confirm Diagnosis: Patients who cannot be confirmed as having primary stage III gastric or gastroesophageal junction adenocarcinoma through histological or cytological examination.
- Inability to Receive Treatment: Patients who are unable to receive immune checkpoint inhibitors or SOX chemotherapy.
- Inability to Comply with Follow-up: Patients who are unable to adhere to the predetermined clinical follow-up schedule.
- Inability to Accept Study Protocol: Patients who cannot accept the treatment regimen specified in the study protocol.
- Inability to Provide Efficacy Assessment: Patients who cannot undergo or provide designated efficacy assessment methods such as CT scans.
- Autoimmune Diseases: Patients with a history of autoimmune diseases. Psychiatric or Substance Abuse Issues: Patients with a history of substance abuse that cannot be discontinued or those with psychiatric disorders, or any severe and/or uncontrolled medical conditions.
- Severe Comorbidities: Patients with any severe comorbidities that, in the investigator's judgment, may jeopardize patient safety or completion of the study.
- Pregnancy or Breastfeeding: Pregnant or breastfeeding women. Prior Neoadjuvant Therapy: Patients who received neoadjuvant therapy prior to surgery or intraoperative chemotherapy infusion.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT06939439
Start Date
December 1 2024
End Date
December 31 2029
Last Update
July 1 2025
Active Locations (1)
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1
First Affiliated Hospital with Nanjing Medical Unviersity
Nanjing, Jiangsu, China, 210029