Microwave Ablation Combined With Camrelizumab in the Treatment of Early Breast Cancer

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT04805736
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Microwave Ablation — PROCEDURE
    Image-guided microwave ablation 7-10 days prior to surgery
  • Camrelizumab — DRUG
    Camrelizumab 200 mg was given a few days after microwave ablation
  • Breast Surgery — PROCEDURE
    Standard of care breast conserving surgery or radical mastectmoy

Study Details

Ablative therapy, as a local treatment modality for tumors, has an immune activating effect. To explore the synergistic effect of microwave ablation combined with PD-1 inhibitors, this prospective, open-label, multi-cohort, single-center clinical study was conducted. To compare the feasibility and safety of preoperative microwave ablation alone, with or without camrelizumab in patients with early newly diagnosed breast cancer.

Key Dates

Start date
Mar 25, 2021
Status verified
Jan 2024
Primary completion
Apr 30, 2023
Completion
Apr 30, 2023

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Microwave Ablation alone
    Microwave Ablation+ Breast Surgery
  • Experimental: Camrelizumab alone
    Camrelizumab+ Breast Surgery
  • Experimental: Microwave Ablation & Camrelizumab
    Microwave Ablation + Camrelizumab + Breast Surgery

Primary Outcome Measure

Safety of Microwave Ablation Combined With Camrelizumab [ Time Frame: 3 months ]

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