Breast CancerPhase 2NCT04805736
Microwave Ablation Combined With Camrelizumab in the Treatment of Early Breast Cancer
A Phase 2 study testing Microwave Ablation, Camrelizumab and Breast Surgery in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Microwave Ablation, Camrelizumab and Breast Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2021to 30 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female.
- Age 20-65 years.
- Invasive carcinoma confirmed by core biopsy.
- Newly diagnosed breast cancer patients, without adjuvant therapy.
- 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.
- Systematic ultrasound is able to visualize lesions.
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- Surgical treatment was planned.
- The functional level of major organs must meet the following requirements:
- blood routine: neutrophil (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L; hemoglobin (Hb) ≥ 90 g/L;
- 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;
- coagulation: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Heart: left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography (ECHO) or multigated acquisition (MUGA).
- 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.
- Urinalysis: urine protein < 2 +, if urine protein ≥ 2 +, 24-hour urine protein quantification must show protein ≤ 1 g.
- Voluntarily participate in this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
Who cannot join
- Tumor involving skin, ulceration, inflammatory breast cancer patients
- Fatty breast cancer.
- Tumors on the deep surface of areolar region
- KPS score < 70, or ECOG score > 2
- Patients with a history of concomitant collagen connective tissue disease, or any active autoimmune disease or autoimmune disease.
- Prior radiotherapy or prior use of investigational drugs or other immunosuppressive agents
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- Heart, brain, lung, kidney and other vital organ failure, liver and kidney dysfunction;
- Uncorrectable severe coagulopathy
- Patient is pregnant or lactating
- Poor glycemic control in diabetes
- Patients with foreign body implantation around the tumor
- Patients with severe scars on the skin of the treatment area (protruding from the skin surface, width ≥ 1 cm)
- History of chronic immunosuppression, prior immunotherapy, recent vaccination (< 4 weeks)
- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
About this study
Official title: A Pilot Study of Single-Dose Camrelizumab and/or Microwave Ablation in Women With Early-Stage Breast Cancer
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
- Being tested
- Microwave Ablation, Camrelizumab, Breast Surgery
- Keywords
- Ablation, PD-1, Immunotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave AblationProcedure or surgery
Image-guided microwave ablation 7-10 days prior to surgery
CamrelizumabDrug
Also called SHR-1210
Camrelizumab 200 mg was given a few days after microwave ablation
Breast SurgeryProcedure or surgery
Standard of care breast conserving surgery or radical mastectmoy
| Study group | Role | What they receive |
|---|---|---|
| Microwave Ablation alone | Experimental | Microwave Ablation+ Breast Surgery Receives: Procedure: Microwave Ablation; Procedure: Breast Surgery |
| Camrelizumab alone | Experimental | Camrelizumab+ Breast Surgery Receives: Drug: Camrelizumab; Procedure: Breast Surgery |
| Microwave Ablation & Camrelizumab | Experimental | Microwave Ablation + Camrelizumab + Breast Surgery Receives: Procedure: Microwave Ablation; Drug: Camrelizumab; Procedure: Breast Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Microwave Ablation Combined With Camrelizumab
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
Measured: 3 months
Secondary outcomes (4)
Complete ablation rate
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.
Measured: 1 day
Negative predictive value of ultrasound
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
Measured: 1 day
Assessment of Immunogenicity
Proportion of subjects with immune response to synergistic therapy detected by biomarkers in peripheral blood samples
Measured: 3 months
Breast self evaluation
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start25 Mar 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Shui Wang, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805736
- Sponsor's protocol ID
- MA-BC-Ⅱ-021
- Status last verified
- Jan 2024
- First submitted
- 10 Mar 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available from the corresponding author upon reasonable request
Publications
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.
PubMed 38417440
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Single-Dose Camrelizumab and/or Microwave Ablation in Women With Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT04805736
- Acronym / sponsor ID
- MA-BC-Ⅱ-021
- Conditions
- Breast Cancer
- Keywords
- Ablation, PD-1, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Microwave Ablation alone | Experimental | Procedure: Microwave Ablation, Procedure: Breast SurgeryMicrowave Ablation+ Breast Surgery |
| Camrelizumab alone | Experimental | Drug: Camrelizumab, Procedure: Breast SurgeryCamrelizumab+ Breast Surgery |
| Microwave Ablation & Camrelizumab | Experimental | Procedure: Microwave Ablation, Drug: Camrelizumab, Procedure: Breast SurgeryMicrowave Ablation + Camrelizumab + Breast Surgery |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Female.
- Age 20-65 years.
- Invasive carcinoma confirmed by core biopsy.
- Newly diagnosed breast cancer patients, without adjuvant therapy.
- 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.
Key exclusion criteria (15 listed)
- Tumor involving skin, ulceration, inflammatory breast cancer patients
- Fatty breast cancer.
- Tumors on the deep surface of areolar region
- KPS score < 70, or ECOG score > 2
- Patients with a history of concomitant collagen connective tissue disease, or any active autoimmune disease or autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave AblationImage-guided microwave ablation 7-10 days prior to surgery | Procedure or surgery | Microwave Ablation & Camrelizumab, Microwave Ablation alone |
| CamrelizumabAlso: SHR-1210Camrelizumab 200 mg was given a few days after microwave ablation | Drug | Camrelizumab alone, Microwave Ablation & Camrelizumab |
| Breast SurgeryStandard of care breast conserving surgery or radical mastectmoy | Procedure or surgery | Camrelizumab alone, Microwave Ablation & Camrelizumab, Microwave Ablation alone |
Primary outcome
Safety of Microwave Ablation Combined With Camrelizumab
Time frame: 3 months
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
4 secondary outcomes
Complete ablation rate
Time frame: 1 day
Negative predictive value of ultrasound
Time frame: 1 day
Assessment of Immunogenicity
Time frame: 3 months
Breast self evaluation
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 38417440Pan 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.
- Individual participant dataSharing planned: Yes. Available from the corresponding author upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Microwave Ablation, Camrelizumab and Breast Surgery in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Microwave Ablation Combined With Camrelizumab (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04805736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.