About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18-75 years old, both genders are eligible.
Undifferentiated pleomorphic sarcoma
Liposarcoma
Leiomyosarcoma
Disqualifiers
Gastrointestinal Stromal Tumor (GIST)
Osteosarcoma
Ewing's Sarcoma
Previous radiotherapy to the same site with a cumulative dose that may exceed the normal tissue tolerance dose
Trial design
Single group
Treatments tested in this trial
Spatially Fractionated Radiation Therapy Combined with Toripalimab and Human Granulocyte-Macrophage Colony-Stimulating Factor for Injection
Drug1. Spatially Fractionated Radiation Therapy: 1. High-dose area: 500-800 cGy × 3 fractions 2. Fraction interval: 1 session of radiotherapy per day, with 3 sessions per cycle 3. High-dose area coverage: 40-60% of the irradiated field area 2. Toripalimab: 1. Dose: 3 mg/kg 2. Frequency: Every 2-3 weeks 3. Administration timing: Within one week after the completion of radiotherapy 3. Human Granulocyte-Macrophage Colony-Stimulating Factor for Injection: 1. Dose: 100-200 µg 2. Frequency: Once daily <!-- --> 1. Administration timing: Starting on the day of radiotherapy, to be used continuously for one week
Treatment groups
Trial outcomes
Primary outcomes
Objective Response Rate
Secondary outcomes
Disease Control Rate
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: