Real-world Study on the Efficacy, Safety, and Prognostic Factors of Immune Checkpoint Inhibitors Combined With Radiotherapy in Patients With Malignant Tumors: A Prospective Non-interventional Clinical Study
Starting soon
Conditions studied: Radiotherapy, Immune Checkpoint Inhibitors (ICIs)
In brief
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.
Key facts
- Study ID
- NCT07665736
- Run by
- Sichuan University
- People needed
- 200
- Starts
- 2026-06-30
- Expected to finish
- 2029-06-15
- Last updated by the study team
- 2026-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years;
- Histologically or cytologically confirmed malignant tumor;
- Planned to receive immunotherapy combined with radiotherapy as the basis of treatment;
- At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
- Adequate organ function (reference may be made to laboratory test indicators, such as routine blood tests, liver and kidney function);
- Voluntarily participate in this study, sign the informed consent form, and agree to comply with follow-up.
You may not qualify if…
- 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;
- Active, uncontrolled serious 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).
Where it is running
- West China Hospital of Sichuan University — Chengdu, China
Full record on ClinicalTrials.gov
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