Soft Tissue Sarcoma (STS)Phase 2NCT07342322
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
A Phase 2 study testing Spatially Fractionated Radiation Therapy Combined with Toripalimab and Human Granulocyte-Macrophage Colony-Stimulating Factor for Injection in people with Soft Tissue Sarcoma (STS), run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Soft Tissue Sarcoma (STS)
- What is being tested?
- Spatially Fractionated Radiation Therapy Combined with Toripalimab and Human Granulocyte-Macrophage Colony-Stimulating Factor for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 join
- Special Types of Sarcoma:
- Gastrointestinal Stromal Tumor (GIST)
- Osteosarcoma
- Ewing's Sarcoma
- Prior Treatment History:
- Previous radiotherapy to the same site with a cumulative dose that may exceed the normal tissue tolerance dose
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- 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
- Central Nervous System Metastasis: Symptomatic brain or spinal metastasis.
- Pregnancy and Lactation: Women who are pregnant or breastfeeding.
- Allergy History: Known allergies to the drugs or their components involved in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Weimei Huang, 18176887734, huangweimei@gxmu.edu.cn
About this study
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:
- Can spatially fractionated radiotherapy combined with the PraG strategy improve the clinical prognosis of patients?
- 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.
Read more
Participants will:
- 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.
- 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.
- Participants will receive daily oral administration of ABC or placebo for a consecutive 4 months.
- Routine follow-up examinations will be performed at an interval of 8/12 weeks.
- 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)
- Being tested
- Spatially Fractionated Radiation Therapy Combined with Toripalimab and Human Granulocyte-Macrophage Colony-Stimulating Factor for Injection
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatially Fractionated Radiation Therapy Combined with Toripalimab and Human Granulocyte-Macrophage Colony-Stimulating Factor for InjectionDrug
- Spatially Fractionated Radiation Therapy:
- High-dose area: 500-800 cGy × 3 fractions
- Fraction interval: 1 session of radiotherapy per day, with 3 sessions per cycle
- High-dose area coverage: 40-60% of the irradiated field area
- Toripalimab:
- Dose: 3 mg/kg
- Frequency: Every 2-3 weeks
- Administration timing: Within one week after the completion of radiotherapy
- Human Granulocyte-Macrophage Colony-Stimulating Factor for Injection:
- Dose: 100-200 µg
- Frequency: Once daily <!-- -->
- Administration timing: Starting on the day of radiotherapy, to be used continuously for one week
| Study group | Role | What they receive |
|---|---|---|
| SFRT + PraG | Experimental | Not described Receives: Drug: Spatially Fractionated Radiation Therapy Combined with Toripalimab and Human Granulocyte-Macrophage Colony-Stimulating Factor for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: week 4
Secondary outcomes (1)
Disease Control Rate
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma (STS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342322
- Sponsor's protocol ID
- 2025-K0608
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07342322
- Acronym / sponsor ID
- 2025-K0608
- Conditions
- Soft Tissue Sarcoma (STS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can spatially fractionated radiotherapy combined with the PraG strategy improve the clinical prognosis of patients?
- 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:
- 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.
- 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.
- Participants will receive daily oral administration of ABC or placebo for a consecutive 4 months.
- Routine follow-up examinations will be performed at an interval of 8/12 weeks.
- Clinical symptoms, imaging indicators, biochemical parameters and survival status of all participants will be systematically recorded and documented throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SFRT + PraG | Experimental | Drug: Spatially Fractionated Radiation Therapy Combined with Toripalimab and Human Granulocyte-Macrophage Colony-Stimulating Factor for Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age: 18-75 years old, both genders are eligible.
- Pathological Diagnosis: Histologically confirmed soft tissue sarcoma, including but not limited to:
- Disease Stage:
- Prior Therapy:
- Measurable Disease: At least one measurable lesion according to RECIST 1.1 criteria.
Key exclusion criteria (16 listed)
- Special Types of Sarcoma:
- Prior Treatment History:
- Concurrent Diseases:
- Central Nervous System Metastasis: Symptomatic brain or spinal metastasis.
- Pregnancy and Lactation: Women who are pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spatially Fractionated Radiation Therapy Combined with Toripalimab and Human Granulocyte-Macrophage Colony-Stimulating Factor for Injection1. 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 | Drug | SFRT + PraG |
Primary outcome
Objective Response Rate
Time frame: week 4
1 secondary outcome
Disease Control Rate
Time frame: week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spatially Fractionated Radiation Therapy Combined with Toripalimab and Human Granulocyte-Macrophage Colony-Stimulating Factor for Injection in people with Soft Tissue Sarcoma (STS), run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Lv (86 + 13481095127, 87800197@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.