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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICI plus chemotherapy |
| ||
| Chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICI plus Chemothearpy | Drug | This intervention involves the administration of immune checkpoint inhibitors (ICIs) in combination with standard chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The time from the starting date of study drug to death | 12 months after the last subject participating in |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) as assessed by RECIST1.1 | The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD)in total subjects. | 6 months after the last subject participating in |
| Duration of response (DOR) as assessed by RECIST1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with pathologically defined, locally inoperable or advanced gastric cancer who have not received any previous anti-tumor therapy and are expected to receive immunotherapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lian Liu, MD | Contact | 0531-82169851 | tounao@126.com | |
| Song Li, MD | Contact | 0531-82169851 |
| Name | Affiliation | Role |
|---|---|---|
| Lian Liu, MD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Collect the peripheral blood and feces of patients before and after treatment, and obtain pathological sections if possible.
| Chemotherapy | Drug | This intervention involves the administration of standard chemotherapy alone. |
|
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. |
| 12 months after the last subject participating in |
| Number of participants with treatment-related adverse events as assessed by CTCAE5.0 | 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). | 12 months after the last subject participating in |
| Progression-free survival (PFS) as assessed by RECIST1.1 | The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first | 12 months after the last subject participating in |
| Objective remission rate (ORR) as assessed by RECIST1.1 | The proportion of subjects with complete response (CR) and partial response (PR) in total subjects | 3 months after the last subject participating in |
| Disease-free survival (DFS) as assessed by RECIST1.1 | The period from treatment until the occurrence of disease recurrence, progression, or death. | 36 months after the last subject participating in |
| Major pathological response (MPR) | he percentage of residual viable tumor cells in the resected specimen that is ≤10% after neoadjuvant therapy. | 3 months after the last subject participating in |