Radiotherapy-Induced Immune PrimingPhase 1/2NCT07774819
Spatially Fractionated Radiotherapy for Tumor Treatment
A Phase 1/2 study testing spatially fractionated radiotherapy in people with Radiotherapy-Induced Immune Priming, run by Xu Zhi-yuan at 1 site in China.
Trial summary
To explore the efficacy and toxicity of spatially fractionated radiotherapy in the treatment of tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiotherapy-Induced Immune Priming
- What is being tested?
- spatially fractionated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2024to Dec 2028
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a bulky solid tumor with a maximum diameter >4 cm or a refractory solid tumor.
Who cannot join
- Tumors involving hollow viscera that are considered to have a clinically significant risk of bleeding or perforation.
- Patients with impaired consciousness or who are unable to care for themselves.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, 518053
Zhiyuan Xu, MD, 18307555170, xuzy@hku-szh.org
Yang Li, MD, +86 0755-86913333, yangl1@hku-szh.org
About this study
Official title: Spatially Fractionated Radiotherapy for Bulky or Refractory Solid Tumors: Efficacy and Toxicity
To explore the efficacy and toxicity of spatially fractionated radiotherapy in the treatment of tumors.
Read the detailed description
Spatially fractionated radiotherapy (SFRT) is a next-generation technology for precision cancer treatment. It delivers a highly inhomogeneous dose distribution in three-dimensional space, demonstrating high clinical response rates and minimal toxicity in bulky primary or metastatic malignancies. Conventional radiotherapy, which uniformly irradiates the entire tumor volume, often causes radiation damage to normal tissues, thereby limiting clinical efficacy. In contrast, spatially fractionated radiotherapy divides the treatment volume into sub-volumes, alternating high-dose and low-dose regions among these sub-volumes. Lattice radiotherapy is an advanced technique that integrates the technological advantages of radiosurgery and grid radiotherapy, achieving both biological and physical precision, and represents a novel radiotherapy approach for managing bulky and refractory tumors.
- Conditions
- Radiotherapy-Induced Immune Priming
- Being tested
- spatially fractionated radiotherapy
- Keywords
- Spatially fractionated radiotherapy, Bulky tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spatially fractionated radiotherapyRadiation
spatially fractionated radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| SFRT arm | Experimental | Adding spatially fractionated radiotherapy (SFRT) to standard-of-care treatment. Receives: Radiation: spatially fractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants with treatment-related grade ≥3 adverse events as assessed by CTCAE v5.0
Safety will be assessed by the incidence of treatment-related adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The number and percentage of participants experiencing at least one treatment-related grade ≥3 adverse event during the specified assessment period will be reported. Treatment-related serious adverse events and grade 5 adverse events will also be summarized descriptively.Whether this study can be successfully executed and implemented.
Measured: From initiation of spatially fractionated radiation therapy through 90 days after completion of radiotherapy
Percentage of participants who successfully complete the planned spatially fractionated radiation therapy without treatment discontinuation due to treatment-related toxicity or technical inability to deliver the planned treatment
Feasibility will be assessed by the proportion of enrolled participants who successfully complete the protocol-specified spatially fractionated radiation therapy (SFRT). Successful completion is defined as delivery of the planned SFRT according to the protocol without premature discontinuation due to treatment-related toxicity or technical inability to deliver the planned treatment. The number and percentage of participants meeting this definition will be reported.
Measured: From initiation through completion of the planned spatially fractionated radiation therapy
Secondary outcomes (2)
Objective response rate (ORR) as assessed by RECIST version 1.1
Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response of complete response (CR) or partial response (PR) in the irradiated target lesion(s), as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. The number and percentage of participants achieving CR or PR will be reported.
Measured: From initiation of spatially fractionated radiation therapy until documented disease progression, initiation of subsequent anticancer therapy, death, or the end of follow-up, up to 2 years
Local progression-free survival (LPFS) as assessed by RECIST version 1.1
Local progression-free survival (LPFS) is defined as the time from initiation of spatially fractionated radiation therapy to the first documented local progression of the irradiated target lesion(s), as assessed according to RECIST version 1.1, or death from any cause, whichever occurs first. Participants who are alive without documented local progression at the time of analysis will be censored at the date of their last evaluable tumor assessment. LPFS will be estimated using the Kaplan-Meier method.
Measured: From initiation of spatially fractionated radiation therapy until local disease progression or death from any cause, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start19 Dec 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy-Induced Immune PrimingStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To evaluate the feasibility, safety, and preliminary efficacy of adding spatially fractionated radiotherapy (SFRT) to standard-of-care in patients with bulky or refractory tumors.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu Zhi-yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu Zhi-yuan, The University of Hong Kong-Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774819
- Sponsor's protocol ID
- hkuszhCAMT2024078
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatially Fractionated Radiotherapy for Bulky or Refractory Solid Tumors: Efficacy and Toxicity
- ClinicalTrials.gov ID
- NCT07774819
- Acronym / sponsor ID
- hkuszhCAMT2024078
- Conditions
- Radiotherapy-Induced Immune Priming
- Keywords
- Spatially fractionated radiotherapy, Bulky tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Xu Zhi-yuanUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Aug 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.
To explore the efficacy and toxicity of spatially fractionated radiotherapy in the treatment of tumors.
Detailed description
Spatially fractionated radiotherapy (SFRT) is a next-generation technology for precision cancer treatment. It delivers a highly inhomogeneous dose distribution in three-dimensional space, demonstrating high clinical response rates and minimal toxicity in bulky primary or metastatic malignancies. Conventional radiotherapy, which uniformly irradiates the entire tumor volume, often causes radiation damage to normal tissues, thereby limiting clinical efficacy. In contrast, spatially fractionated radiotherapy divides the treatment volume into sub-volumes, alternating high-dose and low-dose regions among these sub-volumes. Lattice radiotherapy is an advanced technique that integrates the technological advantages of radiosurgery and grid radiotherapy, achieving both biological and physical precision, and represents a novel radiotherapy approach for managing bulky and refractory tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To evaluate the feasibility, safety, and preliminary efficacy of adding spatially fractionated radiotherapy (SFRT) to standard-of-care in patients with bulky or refractory tumors.
| Arm | Type | Receives |
|---|---|---|
| SFRT arm | Experimental | Radiation: spatially fractionated radiotherapyAdding spatially fractionated radiotherapy (SFRT) to standard-of-care treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a bulky solid tumor with a maximum diameter >4 cm or a refractory solid tumor.
Key exclusion criteria (2 listed)
- Tumors involving hollow viscera that are considered to have a clinically significant risk of bleeding or perforation.
- Patients with impaired consciousness or who are unable to care for themselves.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spatially fractionated radiotherapyspatially fractionated radiotherapy | Radiation | SFRT arm |
Primary outcome
Number and percentage of participants with treatment-related grade ≥3 adverse events as assessed by CTCAE v5.0
Time frame: From initiation of spatially fractionated radiation therapy through 90 days after completion of radiotherapy
Safety will be assessed by the incidence of treatment-related adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The number and percentage of participants experiencing at least one treatment-related grade ≥3 adverse event during the specified assessment period will be reported. Treatment-related serious adverse events and grade 5 adverse events will also be summarized descriptively.Whether this study can be successfully executed and implemented.
Percentage of participants who successfully complete the planned spatially fractionated radiation therapy without treatment discontinuation due to treatment-related toxicity or technical inability to deliver the planned treatment
Time frame: From initiation through completion of the planned spatially fractionated radiation therapy
Feasibility will be assessed by the proportion of enrolled participants who successfully complete the protocol-specified spatially fractionated radiation therapy (SFRT). Successful completion is defined as delivery of the planned SFRT according to the protocol without premature discontinuation due to treatment-related toxicity or technical inability to deliver the planned treatment. The number and percentage of participants meeting this definition will be reported.
2 secondary outcomes
Objective response rate (ORR) as assessed by RECIST version 1.1
Time frame: From initiation of spatially fractionated radiation therapy until documented disease progression, initiation of subsequent anticancer therapy, death, or the end of follow-up, up to 2 years
Local progression-free survival (LPFS) as assessed by RECIST version 1.1
Time frame: From initiation of spatially fractionated radiation therapy until local disease progression or death from any cause, up to 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 19 Aug 2026.
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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?
A Phase 1/2 study testing spatially fractionated radiotherapy in people with Radiotherapy-Induced Immune Priming, run by Xu Zhi-yuan 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 19 Aug 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhiyuan Xu, MD (+86 0755-86913333, xuzy@hku-szh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of participants with treatment-related grade ≥3 adverse events as assessed by CTCAE v5.0 (time frame: From initiation of spatially fractionated radiation therapy through 90 days after completion of radiotherapy). 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 19 Aug 2026.