Immune Checkpoint Inhibitors (ICIs), Radiotherapy
Conditions
Brief summary
Currently, chemotherapy, targeted therapy, immunotherapy, and radiotherapy are the core treatment modalities for malignant tumors, with technologies advancing rapidly. Radiotherapy can induce massive tumor cell death in a short period and expose abundant tumor-specific antigens, turning the irradiated tumor into an endogenous tumor vaccine and even causing regression or disappearance of non-irradiated tumors (the abscopal effect) . Preclinical studies have shown that stereotactic body radiotherapy (SBRT) combined with PD-1/PD-L1 inhibitors can activate systemic immunity, sensitize tumor-specific T cells to enter the bloodstream, and enable their homing to distant tumors, thereby inhibiting the growth of non-irradiated tumors . However, conclusions from rigorous randomized controlled trials have limitations when applied to the complex and heterogeneous patient populations in real-world settings. Real-world research is increasingly valued globally to complement traditional clinical trial evidence. This project prospectively collects data from patients receiving immunotherapy combined with radiotherapy in real-world clinical practice, which is of great value for evaluating long-term efficacy, safety, and impact on quality of life, and can provide high-level evidence for optimizing clinical practice and informing healthcare decisions.
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 immunotherapy combined with radiotherapy as the basis of treatment; 4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1); 5. Adequate organ function (reference may be made to laboratory test indicators, such as routine blood tests, liver and kidney function); 6. Voluntarily participate in this study, sign the informed consent form, and agree to comply with follow-up.
Exclusion criteria
1. Patients with severe cognitive impairment, mental illness, or other conditions that, in the judgment of the investigator, preclude them from cooperating with participation in this study; 2. Active, uncontrolled serious 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 |
|---|---|
| progression-free time | 2 years |
| overall survival | 2 years |
Countries
China
Contacts
CONTACTXue Jianxin, MD. Phd
Outcome results
None listed