RadiotherapyNCT07665736
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
An observational study of Radiotherapy and Immune Checkpoint Inhibitors (ICIs), run by Sichuan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy, Immune Checkpoint Inhibitors (ICIs)
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 15 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this 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.
- Conditions
- Radiotherapy, Immune Checkpoint Inhibitors (ICIs)
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free time
Measured: 2 years
overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion15 Jun 2029 (estimated)
- Study completion15 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, You Lu, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665736
- Sponsor's protocol ID
- （2026）355
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07665736
- Acronym / sponsor ID
- （2026）355
- Conditions
- Radiotherapy, Immune Checkpoint Inhibitors (ICIs)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 15 Jun 2029 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
progression-free time
Time frame: 2 years
overall survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy and Immune Checkpoint Inhibitors (ICIs), run by Sichuan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xue Jianxin, MD. Phd (18982251798, killercell@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free time (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.