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

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.

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Key information

Conditions

Radiotherapy Immune Checkpoint Inhibitors (ICIs)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital of Sichuan University

Chengdu, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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).

Treatment and study plan

Primary outcomes

progression-free time

Time frame: 2 years
overall survival

Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Xue Jianxin, MD. Phd

CONTACT

[email protected]

18982251798

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Jun 24, 2026
Registry last updated: Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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