A Prospective, Multicenter, Open-label, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Spatially Fractionated Radiotherapy Combined With the PraG Strategy for the Treatment of Soft Tissue Sarcoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Guangxi Medical University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Spatially Fractionated Radiation Therapy Combined with Toripalimab and Human Granulocyte-Macrophage Colony-Stimulating Factor for Injection

    Drug

    1. 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

25 Participants
are divided into 1 treatment group
Group A: SFRT + PraGExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate

Time frame
week 4

Secondary outcomes

1

Disease Control Rate

Time frame
week 4

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: