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NCT Number: NCT07774819

Spatially Fractionated Radiotherapy for Tumor Treatment

To explore the efficacy and toxicity of spatially fractionated radiotherapy in the treatment of tumors.

Recruiting

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Key information

Conditions

Radiotherapy-Induced Immune Priming

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a bulky solid tumor with a maximum diameter >4 cm or a refractory solid tumor.

Exclusion criteria

  • 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.

Treatment and study plan

Spatially fractionated radiotherapy

Radiation

spatially fractionated radiotherapy

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

Study contacts

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

Zhiyuan Xu, MD

CONTACT

[email protected]

+86 0755-86913333

Sponsors and collaborators

Lead sponsor

Xu Zhi-yuan

Other

Registry information

Official study title

Spatially Fractionated Radiotherapy for Bulky or Refractory Solid Tumors: Efficacy and Toxicity

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 19, 2026
Registry last updated
Aug 19, 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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