Cryoablation Plus Camrelizumab for Advanced Soft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-70
SponsorSun Yat-sen University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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 ;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Cryoablation therapy + anti-PD-1 antibody
DrugAll 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.
Treatment groups
57 Participants
are divided into 1 treatment groupGroup A: Cryoablation therapy combined with PD-1 antibody camrelizumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
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. ISecondary outcomes
1
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.Sponsors and contacts
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Source ClinicalTrials.gov