Radiotherapy-Induced Immune Priming
Conditions
Keywords
Spatially fractionated radiotherapy, Bulky tumor
Brief summary
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.
Interventions
RADIATIONspatially fractionated radiotherapy
spatially fractionated radiotherapy
Sponsors
Xu Zhi-yuan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and percentage of participants with treatment-related grade ≥3 adverse events as assessed by CTCAE v5.0 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) as assessed by RECIST version 1.1 | 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. |
| Local progression-free survival (LPFS) as assessed by RECIST version 1.1 | 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. |
Countries
China
Contacts
CONTACTZhiyuan Xu, MD
Outcome results
None listed