Adverse Event, Efficacy, Team
Conditions
Keywords
PD(L)-1 inhibitor, efficacy, adverse event
Brief summary
This retrospective study will leverage previous immune function monitoring results in conjunction with clinical case data at this medical center.
Detailed description
The primary aim of this study is to evaluate the efficacy and safety of PD(L)-1 antibody therapy for malignant tumors in real-world settings. Treatment outcomes will be assessed according to RECIST V1.1 and iRECIST criteria, with safety graded according to CTCAE V5.0 standards. The study aims to enroll 3000 adult cancer patients treated at this center and analyze their prognosis outcomes based on previous treatment.
Interventions
DRUGPD-1 Inhibitors
Patients received PD-1 inhibitors mono- or combined therapy in real-world clinical practice
Sponsors
Quanli Gao
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. Pathologically confirmed malignant tumors. 3. Complete medical records. 4. Assessable immune function test data.
Exclusion criteria
1. Age \<18 years. 2. No confirmed tumor pathology. 3. Untraceable medical records. 4. Non-assessable immune function tests.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 6 months | The objective response rate at 6 months |
| Adverse events | 1 year | Number of participants who experienced immune-related adverse events at 1 year according to CTCAE 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 1 year | The overall survival rate at 1 year |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of response | 2 years | The duration of response at 2-year |
Countries
China
Contacts
Primary ContactXiaomin Fu
Backup ContactXiaomin Fu
Outcome results
None listed