BridgeMD
New treatment option for Soft Tissue Sarcoma (STS)
Official title Cryoablation Plus Camrelizumab for Advanced Soft Tissue Sarcoma
ClinicalTrials.gov ID: NCT07602049
What this study is testing
What is Cryoablation therapy + anti-PD-1 antibody?
Cryoablation therapy + anti-PD-1 antibody is an investigational medicine, being studied as a potential treatment for soft tissue sarcoma (sts).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 70
You may be able to join if
- 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;
You likely can't join if
- Concurrently having other malignant tumors within 5 years.;
- Patients who received major surgeries, conventional chemotherapy, large-area radiotherapy, biotherapy or treatment ablation therapy for anti-tumor...
- 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...
- Combined with other serious organic diseases and mental disorders;
See the full eligibility criteria
- 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.)...
- 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...
- Concurrently having other malignant tumors within 5 years.;
- Patients who received major surgeries, conventional chemotherapy, large-area radiotherapy, biotherapy or treatment 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...
- Combined with other serious organic diseases and mental disorders;
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.