Actively Recruiting
Prospective Cohort Study on First-Line and Neoadjuvant Therapy Using Immune Checkpoint Inhibitors Combined With Chemotherapy for Advanced Gastric Cancer
Led by Qilu Hospital of Shandong University · Updated on 2024-12-11
500
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of immune checkpoint inhibitors combined with chemotherapy as first-line and neoadjuvant treatments for advanced gastric cancer. This observational study also aims to investigate biomarkers to better understand how these immunotherapies work in patients with advanced or locally advanced gastric cancer. The research is sponsored by Qilu Hospital of Shandong University and focuses on outcomes important to patients receiving these therapies. Participants will receive either immune checkpoint inhibitors combined with standard chemotherapy or chemotherapy alone as part of their treatment. The study observes how these treatments perform in real-world settings without assigning treatments randomly. Researchers will monitor participants over time to collect data on survival, disease control, tumor response, and treatment side effects according to recognized assessment criteria. During the study, participants will undergo regular evaluations including scans and clinical assessments to measure overall survival, progression-free survival, disease control rate, and other outcomes up to 36 months after treatment. Safety will be monitored by tracking any adverse events related to the therapies. The study will follow participants for at least one year after the last person joins to gather comprehensive data on treatment effects and tolerability.
CONDITIONS
Brief Title
First-Line and Neoadjuvant Immunotherapy for Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years old or above
- Diagnosis of advanced gastric cancer or locally advanced gastric cancer
- No previous anti-tumor therapy received
- Planned to receive immunotherapy as first-line or neoadjuvant treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Adequate organ function
You will not qualify if you...
- Contraindications to immunotherapy
- Previous anti-tumor treatments such as immunotherapy or chemotherapy
- History of active immune deficiency or autoimmune disease, including HIV positive, or history of organ transplantation
- Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral treatment
- History of active tuberculosis infection within one year before recruitment unless properly treated
- History of allogeneic stem cell or organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of active treatment as per clinical plan
Participants receive first-line or neoadjuvant immunotherapy combined with chemotherapy or chemotherapy alone.
Visits occur as per treatment schedule
Duration - Up to 36 months after treatment
Participants are monitored for survival, disease control, response duration, and treatment-related adverse events after treatment ends.
Periodic visits for assessments up to 36 months
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
L
Lian Liu, MD
S
Song Li, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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