Using immunotherapy and chemotherapy for advanced gastric cancer treatment
Prospective Cohort Study on the Efficacy, Adverse Effects, and Biomarkers of First-Line/Neoadjuvant Therapy With Immune Checkpoint Inhibitors Combined With Chemotherapy in Advanced Gastric Cancer
This study is testing if combining immunotherapy with chemotherapy can help people with advanced gastric cancer feel better and improve their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06727981 on ClinicalTrials.gov |
What this trial studies
This prospective observational study evaluates the efficacy and safety of immune checkpoint inhibitors combined with chemotherapy as first-line and neoadjuvant therapy for patients with advanced gastric cancer. The study also aims to investigate relevant biomarkers to enhance understanding of immunotherapy outcomes. Eligible participants include those who have not received prior anti-tumor therapy and are expected to receive immunotherapy. The study is conducted at Qilu Hospital of Shandong University in Jinan, Shandong.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced or locally advanced gastric cancer who have not undergone previous anti-tumor therapy.
Not a fit: Patients with contraindications to immunotherapy or those who have received prior anti-tumor treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced gastric cancer.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches in treating gastric cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years old or above 2. Patients with advanced gastric cancer or locally advanced gastric cancer 3. Have not received any previous anti-tumor therapy 4. Patients expected to receive immunotherapy for first-line or neoadjuvant therapy 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 6. Adequate organ function Exclusion Criteria: 1. Patients with contraindications to immunotherapy 2. Have received anti-tumor treatments such as immunotherapy and chemotherapy 3. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases 4. Severe chronic or active infection requires systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection. Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment 5. History of allogeneic stem cell transplantation or organ transplantation
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Lian Liu, MD — Qilu Hospital of Shandong University
- Study coordinator: Lian Liu, MD
- Email: tounao@126.com
- Phone: 0531-82169851
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.