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

NCT07665736 | Not Yet Recruiting

• 1 other identifier: （2026）355
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiotherapy; Immune Checkpoint Inhibitors (ICIs)

Outcome Measures

Primary Outcomes (2)

• progression-free time

  2 years

• overall survival

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged ≥18 years with histologically or cytologically confirmed malignant tumors who are planned to receive treatment based on immune checkpoint inhibitors combined with radiotherapy.

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).

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, 610041, China

Location

Central Study Contacts

Xue Jianxin, MD. Phd

CONTACT

18982251798; killercell@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 24, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): June 15, 2029
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)