NCT06727981Recruiting
First-Line and Neoadjuvant Immunotherapy for Gastric Cancer
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
Source: ClinicalTrials.gov · Last updated 11 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This prospective observational study aims to evaluate the efficacy and safety of immune checkpoint inhibitors as first-line and neoadjuvant therapy for advanced gastric cancer, while also investigating relevant biomarkers to better understand their role in immunotherapy outcomes
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 27 Sept 2024
- Start date
- 15 Jan 2022
- Primary completion date
- 15 Jan 2027
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06727981
What you commit to
- Study type: Observational
- Planned participants: 500
- From 15 Jan 2022 to the primary completion date, 15 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with contraindications to immunotherapy
- Have received anti-tumor treatments such as immunotherapy and chemotherapy
Other illness
- 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
- 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
- History of allogeneic stem cell transplantation or organ transplantation
Who the study is looking for
- Age 18 years old or above
- Patients with advanced gastric cancer or locally advanced gastric cancer
- Have not received any previous anti-tumor therapy
- Patients expected to receive immunotherapy for first-line or neoadjuvant therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Adequate organ function
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.