Cryoablation Plus Camrelizumab for Advanced Soft Tissue Sarcoma

Sponsor
Sun Yat-sen University
Study ID
NCT07602049
Phase
PHASE2
Status
Recruiting
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Conditions

  • Osteosarcoma
  • Soft Tissue Sarcoma (STS)

Eligibility Criteria

Sex
ALL
Age
14 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cryoablation therapy + anti-PD-1 antibody — DRUG
    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.

Study Details

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.

Key Dates

First listed
May 22, 2026
Start date
Nov 20, 2024
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
57 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Overall Response Rate (ORR) [ 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 ]

Central Contacts

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