Clinical trial · Interventional
Microwave Ablation Combined With Camrelizumab in the Treatment of Early Breast Cancer
A Pilot Study of Single-Dose Camrelizumab and/or Microwave Ablation in Women With Early-Stage Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Surgery | Procedure | — | UNRESOLVED |
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Microwave Ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Microwave Ablation alone
- description
- Microwave Ablation+ Breast Surgery
- interventionNames
- Procedure: Microwave Ablation
- Procedure: Breast Surgery
- type
- EXPERIMENTAL
- label
- Camrelizumab alone
- description
- Camrelizumab+ Breast Surgery
- interventionNames
- Drug: Camrelizumab
- Procedure: Breast Surgery
- type
- EXPERIMENTAL
- label
- Microwave Ablation & Camrelizumab
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female. 2. Age 20-65 years. 3. Invasive carcinoma confirmed by core biopsy. 4. Newly diagnosed breast cancer patients, without adjuvant therapy. 5. Imaging findings showed a single breast tumor with a maximum diameter of 3 cm, no distant metastasis, and no invasion of the skin and chest wall. 6. Systematic ultrasound is able to visualize lesions. 7. Surgical treatment was planned. 8. The functional level of major organs must meet the following requirements: 1. blood routine: neutrophil (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L; hemoglobin (Hb) ≥ 90 g/L; 2. blood biochemistry: total bilirubin (TBIL) ≤ upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3. coagulation: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. 4. Heart: left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography (ECHO) or multigated acquisition (MUGA). 5. Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be investigated, and normal T3 and T4 levels can be included. 6. Urinalysis: urine protein \< 2 +, if urine protein ≥ 2 +, 24-hour urine protein quantification must show protein ≤ 1 g. 9. Voluntarily participate in this study, sign informed consent, have good compliance and are willing to cooperate with follow-up. Exclusion Criteria: 1. Tumor involving skin, ulceration, inflammatory breast cancer patients 2. Fatty breast cancer. 3. Tumors on the deep surface of areolar region 4. KPS score \< 70, or ECOG score \> 2 5. Patients with a history of concomitant collagen connective tissue disease, or any active autoimmune disease or autoimmune disease. 6. Prior radiotherapy or prior use of investigational drugs or other immunosuppressive agents 7. Heart, brain, lung, kidney and other vital organ failure, liver and kidney dysfunction; 8. Uncorrectable severe coagulopathy 9. Patient is pregnant or lactating 10. Poor glycemic control in diabetes 11. Patients with foreign body implantation around the tumor 12. Patients with severe scars on the skin of the treatment area (protruding from the skin surface, width ≥ 1 cm) 13. History of chronic immunosuppression, prior immunotherapy, recent vaccination (\< 4 weeks) 14. Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B indicates antigen positive and HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the analytical method). 15. Concurrent medical conditions that, in the judgment of the investigator, would jeopardize the subject's safety, could confound the study results, or affect the subject's completion of this study.
References
Publications (1)
- DERIVEDPan H, Yu M, Tang X, Mao X, Liu M, Zhang K, Qian C, Wang J, Xie H, Qiu W, Ding Q, Wang S, Zhou W. Preoperative single-dose camrelizumab and/or microwave ablation in women with early-stage breast cancer: A window-of-opportunity trial. Med. 2024 Apr 12;5(4):291-310.e5. doi: 10.1016/j.medj.2024.01.015. Epub 2024 Feb 27. PMID 38417440