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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

NCT07342322 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-15

No results posted yet for this study

Summary

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.

Conditions

  • Soft Tissue Sarcoma (STS)

Interventions

DRUG

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

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

Sponsors & Collaborators

  • First Affiliated Hospital of Guangxi Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-02-01
Completion
2029-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07342322 on ClinicalTrials.gov