Drug Therapy, Immune Checkpoint Inhibitors (ICIs), Neoplasms
Conditions
Brief summary
The population receiving immunotherapy is heterogeneous. Multiple factors, including combination treatment modalities, influence the immune response, and survival outcomes also vary among individuals receiving immunotherapy. The aim of this study is to develop and validate a clinical prediction model that can predict survival outcomes of immunotherapy for malignant tumors, and to assess the calibration and discrimination of this model in a prospective independent cohort.
Interventions
None listed
Sponsors
Sichuan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years; 2. Histologically or cytologically confirmed malignant tumor; 3. Planned to receive immune checkpoint inhibitor (e.g., PD-1/PD-L1 inhibitor)-based therapy (monotherapy or in combination with chemotherapy/targeted therapy/radiotherapy, etc.); 4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1); 5. Adequate organ function (with reference to laboratory tests such as complete blood count, liver and kidney function tests); 6. Voluntary participation in this study, signed informed consent, and willingness to comply with follow-up.
Exclusion criteria
1. Active autoimmune disease requiring systemic immunosuppressive therapy (physiological doses of glucocorticoid replacement therapy or inhaled steroids are permitted); 2. Active, uncontrolled severe infection, or known human immunodeficiency virus (HIV) infection; 3. Pregnant or breastfeeding women; 4. Any unstable systemic disease (including but not limited to severe cardiac, hepatic, or renal insufficiency).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 2 year |
| progression-free time | 2 year |
Countries
China
Contacts
CONTACTXue Jianxin, MD. Phd
Outcome results
None listed