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Recruiting Observational

First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

NCT06727981 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2022-01-15
Last updated
2024-12-11

Condition(s) studied

Advanced Gastric CancerLocally Advanced Gastric Carcinoma

Investigational drug(s) / intervention(s)

ICI plus Chemothearpy →Chemotherapy

ICI plus Chemothearpy: This intervention involves the administration of immune checkpoint inhibitors (ICIs) in combination with standard chemotherapy.

Chemotherapy: This intervention involves the administration of standard chemotherapy alone.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Overall survival (OS) — 12 months after the last subject participating in
    The time from the starting date of study drug to death

Trial sites (1)

FacilityCityRegionStatus
Qilu Hospital of Shandong University Jinan Shandong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06727981 on ClinicalTrials.gov ↗ ← All trials in China