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

January 8, 2026 updated by: First Affiliated Hospital of Guangxi Medical University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age: 18-75 years old, both genders are eligible.

  2. Pathological Diagnosis: Histologically confirmed soft tissue sarcoma, including but not limited to:

    • Undifferentiated pleomorphic sarcoma
    • Liposarcoma
    • Leiomyosarcoma
    • Synovial sarcoma
    • Fibrosarcoma
    • Other high-grade soft tissue sarcomas

  3. Disease Stage:

    • Locally advanced, unresectable soft tissue sarcoma, or
    • Recurrent or metastatic soft tissue sarcoma

  4. Prior Therapy:

    • Prior surgery, radiotherapy, or chemotherapy is allowed.
    • At least 4 weeks since the last anti-tumor treatment.
    • Prior treatment-related toxicities have resolved to ≤Grade 1 (except alopecia).
  5. Measurable Disease: At least one measurable lesion according to RECIST 1.1 criteria.
  6. Performance Status: ECOG performance status score of 0-2.
  7. Life Expectancy: ≥3 months.

  8. Organ Function:

    • Hematology: Hemoglobin ≥50 g/L, absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥60×10⁹/L
    • Liver Function: Total bilirubin ≤1.5× upper limit of normal (ULN), ALT and AST ≤2.5× ULN (≤5× ULN for patients with liver metastasis)
    • Renal Function: Serum creatinine ≤1.5× ULN or creatinine clearance ≥50 mL/min
    • Cardiac Function: Left ventricular ejection fraction ≥40%
  9. Informed Consent: The patient or their legal representative has signed the informed consent form.

Exclusion Criteria:

  1. Special Types of Sarcoma:

    • Gastrointestinal Stromal Tumor (GIST)
    • Osteosarcoma
    • Ewing's Sarcoma

  2. Prior Treatment History:

    • Previous radiotherapy to the same site with a cumulative dose that may exceed the normal tissue tolerance dose
    • Major surgery within 4 weeks

  3. Concurrent Diseases:

    • Active autoimmune diseases
    • Diseases requiring systemic immunosuppressive therapy
    • Severe cardiovascular diseases (myocardial infarction, unstable angina, heart failure, etc.)
    • Severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, etc.)
    • Active infections requiring systemic anti-infective therapy
  4. Central Nervous System Metastasis: Symptomatic brain or spinal metastasis.
  5. Pregnancy and Lactation: Women who are pregnant or breastfeeding.
  6. Allergy History: Known allergies to the drugs or their components involved in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SFRT + PraG
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate
Time Frame: week 4
week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease Control Rate
Time Frame: week 4
week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Guangxi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-K0608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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