Analysis of Efficacy and Outcomes of Immunotherapy for Malignant Tumors: A Prospective Non-interventional Clinical Study

Inclusion criteria

• Age ≥ 18 years;
• Histologically or cytologically confirmed malignant tumor;
• 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.);
• At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
• Adequate organ function (with reference to laboratory tests such as complete blood count, liver and kidney function tests);
• Voluntary participation in this study, signed informed consent, and willingness to comply with follow-up.

Exclusion criteria

• Active autoimmune disease requiring systemic immunosuppressive therapy (physiological doses of glucocorticoid replacement therapy or inhaled steroids are permitted);
• Active, uncontrolled severe infection, or known human immunodeficiency virus (HIV) infection;
• Pregnant or breastfeeding women;
• Any unstable systemic disease (including but not limited to severe cardiac, hepatic, or renal insufficiency).