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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Cryoablation Plus Camrelizumab for Advanced Soft Tissue Sarcoma

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

Cryoablation Plus Camrelizumab for Advanced Soft Tissue Sarcoma (NCT07602049) is a Phase 2 interventional studying Soft Tissue Sarcoma (STS) and Osteosarcoma, sponsored by Sun Yat-sen University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Soft Tissue Sarcoma (STS) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 57 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Soft Tissue Sarcoma (STS) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Before any procedures related to the research program, including screening and evaluation stage, signed willing to sign a consent form. 2. Age≥14 years old, and≤70 years old ; 3. Pathologically diagnosed as soft tissue sarcomas, and staging for advanced or unresectable patients ; 4. Patients with standard treatment (such as chemotherapy) failure ; 5. 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; 6. 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. 7. ECOG score 0-1 ( see Appendix ) and expected survival time greater than 3 months ; 8. 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. 9. echocardiography showed left ventricular ejection fraction ≥ 50 %; 10. The results of laboratory tests should meet at least the following indicators : ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Before any procedures related to the research program, including screening and evaluation stage, signed informed consent. 2. Age≥14 years old, and≤70 years old ; 3. Pathologically diagnosed as soft tissue sarcomas, and staging for advanced or unresectable patients ; 4. Patients with standard treatment (such as chemotherapy) failure ; 5. 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; 6. 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. 7. ECOG score 0-1 ( see Appendix ) and expected survival time greater than 3 months ; 8. 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. 9. echocardiography showed left ventricular ejection fraction ≥ 50 %; 10. 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. Exclusion Criteria: 1. Concurrently having other malignant tumors within 5 years.; 2. 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; 3. known for any component of this test treatment will produce allergic reactions ; 4. No recovery from previous surgery or treatment-related adverse reactions to \< Level 2 CTCAE; 5. 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. 6. Combined with other serious organic diseases and mental disorders; 7. 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. 8. 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.) 9. 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.). 10. History of organ transplantation, autologous / allogeneic stem cell transplantation and renal replacement therapy; 11. known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure; 12. Known alcohol and/or drug abuse; 13. Pregnant or lactating women; 14. With any researchers determine that may damage the test carried out in the coexistence of medical conditions or diseases of the test; 15. No legal capacity / limited capacity.

Treatments Being Tested

DRUG

Cryoablation therapy + anti-PD-1 antibody

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sun Yat-Sen Univerisity
Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07602049), the sponsor (Sun Yat-sen University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07602049 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07602049?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07602049?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07602049. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07602049. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.