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The primary objective of this clinical trial is to evaluate the efficacy and safety of spatially fractionated radiotherapy combined with the PraG strategy in the treatment of soft tissue sarcoma (STS). The main questions it aims to answer are: 1. Can spatially fractionated radiotherapy combined with the PraG strategy improve the clinical prognosis of patients? 2. What medical adverse events and clinical problems will participants encounter during the treatment with spatially fractionated radiotherapy combined with the PraG strategy? Researchers will administer a combined therapeutic regimen consisting of spatially fractionated radiotherapy, Toripalimab, recombinant human granulocyte-macrophage colony-stimulating factor injection, and Thymalfasin injection to enrolled patients, so as to observe the efficacy and safety of this therapeutic strategy for soft tissue sarcoma. Participants will: 1. The treatment will be divided into two major phases: the radiotherapy phase and the immunotherapy phase, with concomitant immunomodulatory supportive therapy administered throughout the entire treatment course. 2. The total duration of treatment will last for 1 year starting from the first dose of medication, with regular clinical evaluations conducted according to the individual disease characteristics of each patient. 3. Participants will receive daily oral administration of ABC or placebo for a consecutive 4 months. 4. Routine follow-up examinations will be performed at an interval of 8/12 weeks. 5. Clinical symptoms, imaging indicators, biochemical parameters and survival status of all participants will be systematically recorded and documented throughout the study period.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
the First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Start Date
February 1, 2026
Primary Completion Date
February 1, 2026
Completion Date
January 31, 2029
Last Updated
January 15, 2026
25
ESTIMATED participants
Spatially Fractionated Radiation Therapy Combined with Toripalimab and Human Granulocyte-Macrophage Colony-Stimulating Factor for Injection
DRUG
Lead Sponsor
First Affiliated Hospital of Guangxi Medical University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07401355