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Completed

NCT Number: NCT03240224

Bioinformation Therapy for Breast Cancer

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

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Key information

Conditions

Advanced Breast Cancer

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Fuda cancer institute of Fuda cancer hospital

Guangzhou, Guangdong, 510665, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cancer ablation

Device

Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.

Other names: Cryoablation or irreversible electroporation

Life information rehabilitation therapy

Drug

Each treatment: one bottle solution each day, consecutive 3 months, oral administration

Other names: "Qilisheng" Immunoregulatory Oral Solution

Primary outcomes

  1. Relief degree of tumors

    Time frame: 3 months

    It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

Secondary outcomes

  1. Progress free survival（PFS）

    Time frame: 1 year

    The duration between treatment and cancer recurrence

  2. Overall survival（OS）

    Time frame: 3 years

    The duration between treatment and patient pass away

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Collaborators

  • Shengxin Biotechnology Institute, Beijing

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 7, 2017
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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