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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteosarcoma; Soft Tissue Sarcoma (STS)
• Intervention / Treatment: Drug: Cryoablation therapy + anti-PD-1 antibody

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 Type: Interventional
• Enrollment (Estimated): 57
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xing Zhang; Phone Number: 86-020-87343192; Email: zhangxing@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-Sen Univerisity
      • Contact: Zhang; Phone Number: 86-020-87343192; Email: zhangxing@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cryoablation therapy combined with PD-1 antibody camrelizumab; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is the time from treatment initiation until death from any cause	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.

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Sarcoma; Osteosarcoma
• Other Study ID Numbers: SunYat-senU-B2023-265

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No