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Not yet taking people in ChinaPhase 2

Tests a combined radiotherapy and immunotherapy approach for soft tissue sarcoma

Tests spatially fractionated radiotherapy with immune treatments in adults with soft tissue sarcoma.

Key facts

Who runs it
First Affiliated Hospital of Guangxi Medical University
Where
Nanning, ChinaSee the site
Trial code
Registry 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
Status
Not yet recruiting
Phase
Phase 2
People taking part
25 people, planned
Started
1 Feb 2026
Expected to end
31 Jan 2029
Type of study
Interventional
Treatments tested
  • Spatially Fractionated Radiation Therapy Combined with Toripalimab and Human Granulocyte-Macrophage Colony-Stimulating Factor for Injection
Record updated
15 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with soft tissue sarcoma that cannot be removed by surgery, has come back or has spread. They would get spatially fractionated radiotherapy with Toripalimab, GM-CSF and Thymalfasin.

Age
18 to 75 years
Sex
Women and men can join.
Disease stage
Locally advanced soft tissue sarcoma that cannot be removed by surgery, or sarcoma that has come back or spread. At least one lesion that can be measured on scans (RECIST 1.1).
Earlier treatment
Earlier surgery, radiotherapy or chemotherapy is allowed. At least 4 weeks must have passed since the last anti-tumor treatment. Side effects from earlier treatment must have eased to Grade 1 or milder (hair loss excepted).

Main reasons for not taking part

  • Gastrointestinal stromal tumor, osteosarcoma or Ewing's sarcoma
  • Active autoimmune disease or a disease needing treatment that suppresses the immune system
  • Severe heart or lung disease, or an active infection needing treatment for the whole body
  • Brain or spinal metastasis with symptoms
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Age: 18-75 years old, both genders are eligible
  • 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
  • Disease Stage:; Locally advanced, unresectable soft tissue sarcoma, or; Recurrent or metastatic soft tissue sarcoma
  • 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)
  • Measurable Disease: At least one measurable lesion according to RECIST 1.1 criteria
  • Performance Status: ECOG performance status score of 0-2
  • Life Expectancy: ≥3 months
  • 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%
  • Informed Consent: The patient or their legal representative has signed the informed consent form

Who cannot take part

  • 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
  • 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
  • Allergy History: Known allergies to the drugs or their components involved in the study
  • Special Types of Sarcoma:; Gastrointestinal Stromal Tumor (GIST); Osteosarcoma; Ewing's Sarcoma
  • Central Nervous System Metastasis: Symptomatic brain or spinal metastasis
  • Pregnancy and Lactation: Women who are pregnant or breastfeeding

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

  • The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaContact: Weimei HuangNo longer taking part

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The group in the trial

  • SFRT + PraGTreatment being tested

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Tests a combined radiotherapy and immunotherapy approach for soft tissue sarcomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07342322, who can take part
Record updated
15 January 2026