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

NCT ID: NCT04805736

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-25
• Study Completion Date: 2023-04-30

Brief Summary

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

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Microwave Ablation alone

Microwave Ablation+ Breast Surgery

Group Type: EXPERIMENTAL

Microwave Ablation

Intervention Type: PROCEDURE

Image-guided microwave ablation 7-10 days prior to surgery

Breast Surgery

Intervention Type: PROCEDURE

Standard of care breast conserving surgery or radical mastectmoy

Camrelizumab alone

Camrelizumab+ Breast Surgery

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

Camrelizumab 200 mg was given a few days after microwave ablation

Breast Surgery

Intervention Type: PROCEDURE

Standard of care breast conserving surgery or radical mastectmoy

Microwave Ablation & Camrelizumab

Microwave Ablation + Camrelizumab + Breast Surgery

Group Type: EXPERIMENTAL

Microwave Ablation

Intervention Type: PROCEDURE

Image-guided microwave ablation 7-10 days prior to surgery

Camrelizumab

Intervention Type: DRUG

Camrelizumab 200 mg was given a few days after microwave ablation

Breast Surgery

Intervention Type: PROCEDURE

Standard of care breast conserving surgery or radical mastectmoy

Interventions

Microwave Ablation

Image-guided microwave ablation 7-10 days prior to surgery

Intervention Type: PROCEDURE

Camrelizumab

Camrelizumab 200 mg was given a few days after microwave ablation

Intervention Type: DRUG

Breast Surgery

Standard of care breast conserving surgery or radical mastectmoy

Intervention Type: PROCEDURE

Other Intervention Names

SHR-1210

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shui Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

References

Pan 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.

Reference Type: DERIVED

PMID: 38417440 (View on PubMed)

Other Identifiers

MA-BC-Ⅱ-021

Identifier Type: -

Identifier Source: org_study_id