RecruitingPhase 2NCT07602049

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

Sponsor

Sun Yat-sen University

Enrollment

57 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Osteosarcoma Soft Tissue Sarcoma (STS)

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.

Eligibility

Min Age: 14 YearsMax Age: 70 Years

Inclusion Criteria12

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.
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.
\. During the whole experiment, we can regularly go to the research institutions to carry out relevant testing, evaluation and management.

Exclusion Criteria15

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;
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.

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Interventions

DRUGCryoablation 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.