Bioinformation Therapy for Breast Cancer

Study Overview
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Brief Summary
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The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable breast cancer.

Detailed Description
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By enrolling patients with unresectable breast cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Official Title
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Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Breast Cancer

Conditions
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Advanced Breast Cancer

Intervention / Treatment
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* Device: Cancer ablation
* Drug: Life information rehabilitation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies Body tumor 1-6, with at least one tumor length > 2 cm KPS ≥ 70, lifespan > 6 months Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L Exclusion Criteria: Patients with cardiac pacemaker Patients with brain metastasis Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cancer ablation<br>In this group, the patients will receive ablation therapy (e.g. cryosurgery or irreversible electroporation) first for big tumors (> 2 cm). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). | Device: Cancer ablation<br>* Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.<br>* Other names: Cryoablation or irreversible electroporation;|
| Active Comparator: Life information rehabilitation therapy<br>In this group, the patients will drink Qilisheng Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). | Drug: Life information rehabilitation therapy<br>* Each treatment: one bottle solution each day, consecutive 3 months, oral administration<br>* Other names: Qilisheng Immunoregulatory Oral Solution;|
| Experimental: Combination therapy<br>In this group, the patients will receive combination therapy, including ablation and life information rehabilitation therapy. They will receive ablation therapy (e.g. cryosurgery or irreversible electroporation) first for big tumors (> 2 cm), then drink Qilisheng Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). | Device: Cancer ablation<br>* Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.<br>* Other names: Cryoablation or irreversible electroporation;Drug: Life information rehabilitation therapy<br>* Each treatment: one bottle solution each day, consecutive 3 months, oral administration<br>* Other names: Qilisheng Immunoregulatory Oral Solution;|
| No Intervention: Control<br>In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief degree of tumors | It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST） | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival（PFS） | The duration between treatment and cancer recurrence | 1 year | 
| Overall survival（OS） | The duration between treatment and patient pass away | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer ablation, Life information rehabilitation therapy