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Clinical Trial NCT07342322 for Soft Tissue Sarcoma (STS) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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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 Phase 2 25 Immunotherapy Open-Label

Not yet recruiting
Clinical Trial NCT07342322 is designed to study Treatment for Soft Tissue Sarcoma (STS). This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on February 1, 2026 until the study accrues 25 participants. Led by First Affiliated Hospital of Guangxi Medical University, this study is expected to complete by January 31, 2029. The latest data from ClinicalTrials.gov was last updated on January 15, 2026.
Brief 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 wil...
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Official Title

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

Conditions
Soft Tissue Sarcoma (STS)
Other Study IDs
  • 2025-K0608
NCT ID Number
NCT07342322
Start Date (Actual)
2026-02-01
Last Update Posted
2026-01-15
Completion Date (Estimated)
2029-01-31
Enrollment (Estimated)
25
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSFRT + PraG
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-...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Objective Response Rate
week 4
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Disease Control Rate
week 4
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  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.

  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.

First Affiliated Hospital of Guangxi Medical University logoFirst Affiliated Hospital of Guangxi Medical University
Study Central Contact
Contact: Jun Lv, 86 + 13481095127, [email protected]
1 Study Locations in 1 Countries

Guangxi

the First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China
Weimei Huang, Contact, 18176887734, [email protected]