Advanced Gastric Cancer, Locally Advanced Gastric Carcinoma
Conditions
Brief 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
Interventions
DRUGICI plus Chemothearpy
This intervention involves the administration of immune checkpoint inhibitors (ICIs) in combination with standard chemotherapy.
DRUGChemotherapy
This intervention involves the administration of standard chemotherapy alone.
Sponsors
Qilu Hospital of Shandong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 12 months after the last subject participating in | The time from the starting date of study drug to death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) as assessed by RECIST1.1 | 12 months after the last subject participating in | The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first. |
| Number of participants with treatment-related adverse events as assessed by CTCAE5.0 | 12 months after the last subject participating in | Incidence and severity of adverse effects associated with the treatments, categorized by type and grade according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0). |
| Progression-free survival (PFS) as assessed by RECIST1.1 | 12 months after the last subject participating in | The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first |
| Disease Control Rate (DCR) as assessed by RECIST1.1 | 6 months after the last subject participating in | The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD)in total subjects. |
| Disease-free survival (DFS) as assessed by RECIST1.1 | 36 months after the last subject participating in | The period from treatment until the occurrence of disease recurrence, progression, or death. |
| Major pathological response (MPR) | 3 months after the last subject participating in | he percentage of residual viable tumor cells in the resected specimen that is ≤10% after neoadjuvant therapy. |
| Objective remission rate (ORR) as assessed by RECIST1.1 | 3 months after the last subject participating in | The proportion of subjects with complete response (CR) and partial response (PR) in total subjects |
Countries
China
Contacts
Primary ContactLian Liu, MD
Backup ContactSong Li, MD
Outcome results
None listed