ClinicalTrials.gg
Not yet recruitingNCT07665736Updated Jun 24, 2026

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 in Radiotherapy and Immune Checkpoint Inhibitors (ICIs), sponsored by Sichuan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Sichuan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Radiotherapy
  • Immune Checkpoint Inhibitors (ICIs)
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In context

Lead sponsor

Sichuan University is the lead sponsor of 107 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 18 years;
  2. or cytologically confirmed malignant tumor;
  3. Planned to receive immunotherapy combined with radiotherapy as the basis of treatment;
  4. At least one according to the (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 form, and agree to comply with follow-up.

Exclusion criteria

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 (HIV) infection;
  3. Pregnant or breastfeeding women;
  4. Any unstable systemic disease (including but not limited to severe cardiac, hepatic, or renal insufficiency).
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. progression-free time

    Time frame: 2 years

  2. overall survival

    Time frame: 2 years

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2026; primary completion for Jun 2029, 35 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 19, 2026
First posted
Jun 24, 2026
StartEst.
Jun 30, 2026
Primary completionEst.
Jun 15, 2029
CompletionEst.
Jun 15, 2029
Last update
Jun 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07665736
Lead sponsor
Sichuan University
Responsible party
You Lu (MD. PhD, Sichuan University) — Principal investigator
First posted
Jun 24, 2026
Start date
Jun 30, 2026 (estimated)
Primary completion
Jun 15, 2029 (estimated)
Completion
Jun 15, 2029 (estimated)
Last update
Jun 24, 2026

Study contacts

Xue Jianxin, MD. Phd
Contact
killercell@163.com
18982251798

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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