Soft Tissue Sarcoma (STS)Phase 2NCT07602049
Cryoablation Plus Camrelizumab for Advanced Soft Tissue Sarcoma
A Phase 2 study testing Cryoablation therapy + anti-PD-1 antibody in people with Soft Tissue Sarcoma (STS) and Osteosarcoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The main purpose of this trial is to investigate and evaluate the efficacy of cryoablation combined with camrelizumab treatment to patients with advanced or inoperable soft tissue sarcomas after standard treatment failure. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Soft Tissue Sarcoma (STS), Osteosarcoma
- What is being tested?
- Cryoablation therapy + anti-PD-1 antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2024to 30 Nov 2027
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.
- Age≥14 years old, and≤70 years old ;
- Pathologically diagnosed as soft tissue sarcomas, and staging for advanced or unresectable patients ;
- Patients with standard treatment (such as chemotherapy) failure ;
- No previous treatment with PD-1 antibody ; or those who have previously received PD-1 antibody therapy and progressed at least half a year later;
- According to the RECIST1.1 standard, there are ≥3 measurable lesions; the distribution sites of multiple lesions are in ≤3 organs (which may include the abdominopelvic cavity, extremities, liver, lungs, pleura, etc.); the size of the target lesions is 1.0 - 5.0 cm.
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- ECOG score 0-1 ( see Appendix ) and expected survival time greater than 3 months ;
- Patients with brain metastasis who were stable for at least one month after treatment and who do not require the use of glucocorticoids can be included.
- echocardiography showed left ventricular ejection fraction ≥ 50 %;
- The results of laboratory tests should meet at least the following indicators :
- （1）White blood cell count ≥ 3.0 × 109 / L; （2）absolute neutrophil count ( ANC ) ≥ 1.5 × 109 / L ( without GCSF support ) ; （3）absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 / L; （4）platelet ( PLT ) ≥ 75 × 109 / L; （5）hemoglobin ≥ 10g / dL ( no blood transfusion in the past 7 days ) ; （6）Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy; （7）partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy; （8）serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL / min; （9）Aspartate Aminotransferase (AST/SGOT) ≤ 2 × ULN or 5×ULN (for patients with liver metastases).; （10）Alanine Aminotransferase (ALT/SGPT) ≤ 2 × ULN or 5×ULN (for patients with liver metastases).; （11）total bilirubin ( TBIL ) ≤ 1 × ULN 11. Females with fertility were negative in pregnancy test before treatment ; consent must be given to the use of contraception or the prohibition of same-sex or opposite-sex sexual activity during treatment.
- 12. During the whole experiment, we can regularly go to the research institutions to carry out relevant testing, evaluation and management.
Who cannot join
- Concurrently having other malignant tumors within 5 years.;
- Patients who received major surgeries, conventional chemotherapy, large-area radiotherapy, biotherapy or interventional ablation therapy for anti-tumor treatment within 4 weeks before entering the trial;
- known for any component of this test treatment will produce allergic reactions ;
- No recovery from previous surgery or treatment-related adverse reactions to < Level 2 CTCAE;
- Uncontrolled hypertension ( systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 90 mmHg ) or clinically significant cardiovascular and cerebrovascular diseases ( such as activity ), such as cerebrovascular accident ( within 6 months before the signing of informed consent ), myocardial infarction ( within 6 months before the signing of informed consent ), unstable angina, New York Heart Association ( Appendix ) grade II or above congestive heart failure, or severe arrhythmia can not be controlled with drugs or have a potential impact on research and treatment ; the electrocardiogram showed obvious abnormality or average QTc interval ≥ 450 milliseconds in three consecutive times.
- Combined with other serious organic diseases and mental disorders;
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- Patients with systemic active infections requiring treatment, including active tuberculosis, known HIV-positive patients or clinically active hepatitis A, B, and C patients, in the case of chronic hepatitis B virus infection, the HBV-DNA level should be ≤ 10E3.
- Patients with autoimmune diseases : patients with a history of inflammatory bowel disease and a history of autoimmune diseases ( such as systemic lupus erythematosus, vasculitis, and invasive lung disease ) that were judged by the researchers to be unsuitable for this study need to be excluded. (Patients with vitiligo and those with Hashimoto's thyroiditis with normal thyroid function will not be excluded.)
- During the 4 weeks prior to therapy, if there has been use of chronic systemic corticosteroids, hydroxyurea, immunomodulatory drugs (such as interleukin-2, α or γ interferons, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.).
- History of organ transplantation, autologous / allogeneic stem cell transplantation and renal replacement therapy;
- known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure;
- Known alcohol and/or drug abuse;
- Pregnant or lactating women;
- With any researchers determine that may damage the test carried out in the coexistence of medical conditions or diseases of the test;
- No legal capacity / limited capacity.
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, 1 recruiting
- Recruiting
Sun Yat-Sen Univerisity
Guangzhou, Guangdong, 510000
Zhang, 86-020-87343192, zhangxing@sysucc.org.cn
About this study
Official title: A Prospective, Single-Center, Single-Arm Phase II Clinical Trial of Cryoablation Combined With Camrelizumab in the Treatment of Advanced or Unresectable Soft Tissue Sarcoma Refractory to Standard Therapy
The main purpose of this trial is to investigate and evaluate the efficacy of cryoablation combined with camrelizumab treatment to patients with advanced or inoperable soft tissue sarcomas after standard treatment failure.
Read the detailed description
Soft tissue sarcoma is a malignant tumor originating from mesenchymal tissues, characterized by high heterogeneity. It accounts for 15% to 20% of malignant solid tumors in children and 1% in adults. Although its incidence rate is relatively low, most cases are highly malignant and carry a poor prognosis, with a 5-year survival rate of less than 20% for advanced patients.
In recent years, tumor immunotherapy has emerged as a promising approach for treating malignant tumors alongside surgery, chemotherapy, and radiotherapy. This approach mainly includes immune checkpoint blockade, immunomodulators, adoptive cellular immunotherapy, and tumor vaccines. Among these, PD-1/PD-L1 immune checkpoint inhibitors have shown good efficacy in various solid tumors, such as non-small cell lung cancer and malignant melanoma. PD-1 antibodies have also demonstrated some efficacy in specific types of soft tissue sarcomas, including pleomorphic undifferentiated sarcoma and alveolar soft part sarcoma.
Tumor cryoablation therapy has been successfully applied for local control in multiple tumor types. Cryoablation involves freezing and rewarming, which physically damages tumor tissues. The freeze-thaw process causes tumor cell rupture, generating specific tumor antigens and triggering both specific and non-specific anti-tumor immune responses. This therapy offers precise targeting with a short recovery period.
By cryoablating tumor lesions locally, tumor-specific antigens are generated, enabling the immune system to recognize tumor cells more effectively. Meanwhile, camrelizumab is administered to enhance the immune cells' ability to target and destroy tumor cells. This study primarily aims to evaluate the efficacy and safety of cryoablation combined with the PD-1 antibody camrelizumab in the treatment of advanced or inoperable soft tissue sarcomas that have failed standard treatment, providing a basis for Phase III clinical research.
- Conditions
- Soft Tissue Sarcoma (STS), Osteosarcoma
- Being tested
- Cryoablation therapy + anti-PD-1 antibody
- Medical subject headings
- Sarcoma, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoablation therapy + anti-PD-1 antibodyDrug
All enrolled patients undergo local cryoablation combined with camrelizumab treatment. Baseline evaluations are carried out for all lesions throughout each patient's body. Between one and three lesions are selected for local treatment, while the remaining lesions (no fewer than two) are designated as observation-only. Each group of patients receives cryoablation on the targeted lesions every three weeks, in combination with PD-1 antibody therapy. During the study period, each patient can undergo a maximum of six to eight treatment cycles. If complete remission, partial remission, or stable disease is achieved after six to eight cycles, camrelizumab treatment can be continued until disease progression or the onset of intolerable side effects.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation therapy combined with PD-1 antibody camrelizumab | Experimental | All enrolled patients undergo local cryoablation combined with camrelizumab treatment. Baseline evaluations are carried out for all lesions throughout each patient's body. Between one and three lesions are selected for local treatment, while the remaining lesions (no fewer than two) are designated as observation-only. Each group of patients receives cryoablation on the targeted lesions every three weeks, in combination with PD-1 antibody therapy. During the study period, each patient can undergo a maximum of six to eight treatment cycles. If complete remission, partial remission, or stable disease is achieved after six to eight cycles, camrelizumab treatment can be continued until disease progression or the onset of intolerable side effects. Tumor imaging responses are assessed every six weeks according to RECIST 1.1 criteria. Receives: Drug: Cryoablation therapy + anti-PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR measures the proportion of patients whose tumor shrinks significantly or disappears after treatment. It is typically assessed through imaging scans and provides an early indication of a drug's antitumor activity. However, it does not directly reflect whether patients live longer or experience symptom relief.
Measured: The time frame is typically defined by the first few tumor assessments (e.g., at 6, 12, or 24 weeks after treatment initiation), depending on the protocol. I
Secondary outcomes (1)
Overall Survival (OS)
OS is the time from treatment initiation until death from any cause
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start20 Nov 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2027 (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.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xing Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602049
- Sponsor's protocol ID
- SunYat-senU-B2023-265
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Single-Arm Phase II Clinical Trial of Cryoablation Combined With Camrelizumab in the Treatment of Advanced or Unresectable Soft Tissue Sarcoma Refractory to Standard Therapy
- ClinicalTrials.gov ID
- NCT07602049
- Acronym / sponsor ID
- SunYat-senU-B2023-265
- Conditions
- Soft Tissue Sarcoma (STS), Osteosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 22 May 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 main purpose of this trial is to investigate and evaluate the efficacy of cryoablation combined with camrelizumab treatment to patients with advanced or inoperable soft tissue sarcomas after standard treatment failure.
Detailed description
Soft tissue sarcoma is a malignant tumor originating from mesenchymal tissues, characterized by high heterogeneity. It accounts for 15% to 20% of malignant solid tumors in children and 1% in adults. Although its incidence rate is relatively low, most cases are highly malignant and carry a poor prognosis, with a 5-year survival rate of less than 20% for advanced patients.
In recent years, tumor immunotherapy has emerged as a promising approach for treating malignant tumors alongside surgery, chemotherapy, and radiotherapy. This approach mainly includes immune checkpoint blockade, immunomodulators, adoptive cellular immunotherapy, and tumor vaccines. Among these, PD-1/PD-L1 immune checkpoint inhibitors have shown good efficacy in various solid tumors, such as non-small cell lung cancer and malignant melanoma. PD-1 antibodies have also demonstrated some efficacy in specific types of soft tissue sarcomas, including pleomorphic undifferentiated sarcoma and alveolar soft part sarcoma.
Tumor cryoablation therapy has been successfully applied for local control in multiple tumor types. Cryoablation involves freezing and rewarming, which physically damages tumor tissues. The freeze-thaw process causes tumor cell rupture, generating specific tumor antigens and triggering both specific and non-specific anti-tumor immune responses. This therapy offers precise targeting with a short recovery period.
By cryoablating tumor lesions locally, tumor-specific antigens are generated, enabling the immune system to recognize tumor cells more effectively. Meanwhile, camrelizumab is administered to enhance the immune cells' ability to target and destroy tumor cells. This study primarily aims to evaluate the efficacy and safety of cryoablation combined with the PD-1 antibody camrelizumab in the treatment of advanced or inoperable soft tissue sarcomas that have failed standard treatment, providing a basis for Phase III clinical research.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation therapy combined with PD-1 antibody camrelizumab | Experimental | Drug: Cryoablation therapy + anti-PD-1 antibodyAll enrolled patients undergo local cryoablation combined with camrelizumab treatment. Baseline evaluations are carried out for all lesions throughout each patient's body. Between one and three lesions are selected for local treatment, while the remaining lesions (no fewer than two) are designated as observation-only. Each group of patients receives cryoablation on the targeted lesions every three weeks, in combination with PD-1 antibody therapy. During the study period, each patient can undergo a maximum of six to eight treatment cycles. If complete remission, partial remission, or stable disease is achieved after six to eight cycles, camrelizumab treatment can be continued until disease progression or the onset of intolerable side effects. Tumor imaging responses are assessed every six weeks according to RECIST 1.1 criteria. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.
- Age≥14 years old, and≤70 years old ;
- Pathologically diagnosed as soft tissue sarcomas, and staging for advanced or unresectable patients ;
- Patients with standard treatment (such as chemotherapy) failure ;
- No previous treatment with PD-1 antibody ; or those who have previously received PD-1 antibody therapy and progressed at least half a year later;
Key exclusion criteria (15 listed)
- Concurrently having other malignant tumors within 5 years.;
- Patients who received major surgeries, conventional chemotherapy, large-area radiotherapy, biotherapy or interventional ablation therapy for anti-tumor treatment within 4 weeks before entering the trial;
- known for any component of this test treatment will produce allergic reactions ;
- No recovery from previous surgery or treatment-related adverse reactions to < Level 2 CTCAE;
- Uncontrolled hypertension ( systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 90 mmHg ) or clinically significant cardiovascular and cerebrovascular diseases ( such as activity ), such as cerebrovascular accident ( within 6 months before the signing of informed consent ), myocardial infarction ( within 6 months before the signing of informed consent ), unstable angina, New York Heart Association ( Appendix ) grade II or above congestive heart failure, or severe arrhythmia can not be controlled with drugs or have a potential impact on research and treatment ; the electrocardiogram showed obvious abnormality or average QTc interval ≥ 450 milliseconds in three consecutive times.
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 |
|---|---|---|
| Cryoablation therapy + anti-PD-1 antibodyAll enrolled patients undergo local cryoablation combined with camrelizumab treatment. Baseline evaluations are carried out for all lesions throughout each patient's body. Between one and three lesions are selected for local treatment, while the remaining lesions (no fewer than two) are designated as observation-only. Each group of patients receives cryoablation on the targeted lesions every three weeks, in combination with PD-1 antibody therapy. During the study period, each patient can undergo a maximum of six to eight treatment cycles. If complete remission, partial remission, or stable disease is achieved after six to eight cycles, camrelizumab treatment can be continued until disease progression or the onset of intolerable side effects. | Drug | Cryoablation therapy combined with PD-1 antibody camrelizumab |
Primary outcome
Overall Response Rate (ORR)
Time frame: The time frame is typically defined by the first few tumor assessments (e.g., at 6, 12, or 24 weeks after treatment initiation), depending on the protocol. I
ORR measures the proportion of patients whose tumor shrinks significantly or disappears after treatment. It is typically assessed through imaging scans and provides an early indication of a drug's antitumor activity. However, it does not directly reflect whether patients live longer or experience symptom relief.
1 secondary outcome
Overall Survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
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 22 May 2026.
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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 Cryoablation therapy + anti-PD-1 antibody in people with Soft Tissue Sarcoma (STS) and Osteosarcoma, run by Sun Yat-sen 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 12 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 22 May 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 Xing Zhang (86-020-87343192, zhangxing@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: The time frame is typically defined by the first few tumor assessments (e.g., at 6, 12, or 24 weeks after treatment initiation), depending on the protocol. I). 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 22 May 2026.