the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
NCT Number: NCT04805736
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.
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Notify Me20 year–65 year
Female
Interventional
Phase 2
Nanjing, Jiangsu, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Image-guided microwave ablation 7-10 days prior to surgery
Camrelizumab 200 mg was given a few days after microwave ablation
Other names: SHR-1210
Standard of care breast conserving surgery or radical mastectmoy
Time frame: 3 months
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
Time frame: 1 day
The proportion of patients with complete ablation was calculated for all patients. Complete ablation was defined as: tissue section at the ablation margin that was negative by histochemical staining.
Time frame: 1 day
Preoperative ultrasonography was performed. The negative predictive value of ultrasound was calculated by comparing the pathology report. Negative predictive value = number of patients with negative pathology and negative ultrasound/number of patients with negative ultrasound
Time frame: 3 months
Proportion of subjects with immune response to synergistic therapy detected by biomarkers in peripheral blood samples
Time frame: 3 months
Breast self evaluation for patients will be assessed by Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores.The FACT-B consists of 44 self-report items and assesses the specific breast cancer-related quality of life on 4 general and 1 breast-cancer specific subscale. A higher score indicates a higher cancer-related quality of life.
The First Affiliated Hospital with Nanjing Medical University
Other
A Pilot Study of Single-Dose Camrelizumab and/or Microwave Ablation in Women With Early-Stage Breast Cancer
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