Actively Recruiting
Cryoablation Combined With Camrelizumab for Advanced or Unresectable Soft Tissue Sarcoma After Standard Treatment Failure
Led by Sun Yat-sen University · Updated on 2026-05-22
57
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of cryoablation and the PD-1 antibody camrelizumab for patients with advanced or inoperable soft tissue sarcomas who have not responded to standard treatments. Soft tissue sarcomas are rare malignant tumors with poor prognosis and limited treatment options, especially in advanced stages. This phase II trial aims to assess the effectiveness and safety of this combined approach as a potential new treatment. Participants will receive local cryoablation on selected tumor lesions every three weeks along with camrelizumab therapy. One to three lesions per patient are treated locally, while at least two lesions are observed without direct treatment. Patients may undergo six to eight cycles of this combined treatment. If the disease remains stable or improves, camrelizumab may be continued until disease progression or side effects occur. During the study, tumor responses are monitored every six weeks using imaging scans following RECIST 1.1 criteria. Patients undergo baseline evaluations for all lesions and regular laboratory and heart function tests to ensure safety. The primary outcome measured is the overall response rate to treatment, with secondary outcomes including overall survival. Participants are expected to visit the research center regularly for assessments and treatment over the study period.
CONDITIONS
Brief Title
Cryoablation Plus Camrelizumab for Advanced Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Age between 14 and 70 years old
- Pathological diagnosis of advanced or unresectable soft tissue sarcoma
- Failure of standard treatment such as chemotherapy
- No prior PD-1 antibody treatment or progression at least six months after previous PD-1 therapy
- At least three measurable lesions in up to three organs, with target lesions sized 1.0 to 5.0 cm
- ECOG performance status of 0 to 1 and expected survival over 3 months
- Stable brain metastases for at least one month without need for glucocorticoids
- Left ventricular ejection fraction of 50% or higher by echocardiography
- Laboratory values meeting specific blood counts, liver, kidney, and coagulation test criteria
- Negative pregnancy test for fertile females and agreement to contraception during treatment
- Willingness to attend regular testing, evaluation, and management visits during the study
You will not qualify if you...
- Other malignant tumors within the past 5 years
- Major surgery, chemotherapy, radiotherapy, biotherapy, or interventional ablation within 4 weeks before enrollment
- Allergy to any treatment components
- Unresolved adverse reactions from prior treatments above grade 2 CTCAE
- Uncontrolled hypertension or significant cardiovascular/cerebrovascular diseases
- Severe arrhythmia or abnormal ECG including prolonged QTc interval
- Serious organic diseases or mental disorders
- Active infections requiring treatment, including active tuberculosis, HIV, or active hepatitis
- Autoimmune diseases judged unsuitable for the study, except vitiligo or Hashimoto's thyroiditis with normal thyroid function
- Use of systemic corticosteroids or immunomodulatory drugs within 4 weeks before treatment
- History of organ or stem cell transplantation or renal replacement therapy
- Uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or liver failure
- Known alcohol or drug abuse
- Pregnant or breastfeeding women
- Any other medical condition that may interfere with study or pose risk
- Lack of legal capacity or limited legal capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to six to eight cycles of treatment every three weeks, with possible continuation of camrelizumab until disease progression or intolerable side effects
Participants receive local cryoablation on selected tumor lesions every three weeks combined with camrelizumab immunotherapy. Treatment cycles continue for up to six to eight cycles. If the disease is controlled, camrelizumab treatment may be continued until disease progression or intolerable side effects occur.
Visits every three weeks for treatment and assessments; tumor imaging assessments every six weeks
Trial Site Locations
Total: 1 location
1
Sun Yat-Sen Univerisity
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
X
Xing Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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