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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
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.
Sun Yat-Sen Univerisity
Guangzhou, Guangdong, China
RECRUITINGOverall 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.
Time frame: 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
Overall Survival (OS)
OS is the time from treatment initiation until death from any cause
Time frame: 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.
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