Gastric Cancer, Gastroesophageal Junction Cancer, Immune Checkpoint Inhibitors (ICIs), Retreatment, Second-line
Conditions
Brief summary
This is a single-center, retrospective, observational, real-world study. We collected general and clinical data of patients with advanced gastric cancer who were admitted to the First Affiliated Hospital of Zhengzhou University from January 2018 to July 2024.
Detailed description
All patients received combination therapy with ICIs inhibitors for at least 2 cycles in the first-line and at least 2 cycles of ICI inhibitor-based therapy in the second-line after first-line progression. The efficacy and safety of treatment were evaluated, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), Pattern of immune progression after cross-line therapy, grade 3-5 treatment-related adverse events (TRAEs), and immune-related adverse events (irAEs). Cox regression model was used to investigate the influence of multiple factors on survival.
Interventions
Sponsors
Yongxu Jia
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed metastatic or advanced GC/GEJC; * Received at least 2 cycles of anti-PD-1 or PD-L1 based therapy in the first-line setting; * Receiving at least 2 cycles of ICI-based second-line therapy; * ECOG PS 0 or 1; * Radiographic response was also assessed during treatment and survival.
Exclusion criteria
* patients had other malignancies within the past 5 years; * lack of survival and clinical efficacy data; * combined radiotherapy regimens in the second-line treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 12 months | Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first |
| overall survival (OS) | 12 months | Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate (ORR) | 12 months | The proportion of subjects with complete response (CR) and partial response (PR) in total subjects |
| disease control rate (DCR) | 12 months | The proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD) in total subjects |
| safety | 12 months | Adverse events (AEs) were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. |
Contacts
Primary ContactYongxu Jia Doctor
Outcome results
None listed