First-Line and Neoadjuvant Immunotherapy for Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICI plus Chemothearpy, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Advanced Gastric Cancer, Locally Advanced Gastric Carcinoma. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- Drug ICI plus Chemothearpy
This intervention involves the administration of immune checkpoint inhibitors (ICIs) in combination with standard chemotherapy. - Drug Chemotherapy
This intervention involves the administration of standard chemotherapy alone.
Primary outcome measures
- Overall survival (OS) [Time frame: 12 months after the last subject participating in]
Secondary outcome measures (7)
- Disease Control Rate (DCR) as assessed by RECIST1.1 [Time frame: 6 months after the last subject participating in]
- Duration of response (DOR) as assessed by RECIST1.1 [Time frame: 12 months after the last subject participating in]
- Number of participants with treatment-related adverse events as assessed by CTCAE5.0 [Time frame: 12 months after the last subject participating in]
- Progression-free survival (PFS) as assessed by RECIST1.1 [Time frame: 12 months after the last subject participating in]
- Objective remission rate (ORR) as assessed by RECIST1.1 [Time frame: 3 months after the last subject participating in]
- Disease-free survival (DFS) as assessed by RECIST1.1 [Time frame: 36 months after the last subject participating in]
- Major pathological response (MPR) [Time frame: 3 months after the last subject participating in]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Patients with contraindications to immunotherapy
- Have received anti-tumor treatments such as immunotherapy and chemotherapy
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Qilu Hospital of Shandong University — Jinan
Identifiers
NCT: NCT06727981 · EABI-GC