Back to resultsBioinformation Therapy for Liver Cancer
Primary Purpose
Liver, Cancer of, Non-Resectable
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cancer ablation
Life information rehabilitation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Liver, Cancer of, Non-Resectable focused on measuring Cancer ablation, Life information rehabilitation therapy
Eligibility Criteria
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
Sites / Locations
- Fuda cancer institute of Fuda cancer hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
No Intervention
Arm Label
Cancer ablation
Life information rehabilitation therapy
Combination therapy
Control
Arm Description
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).
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).
In this group, the patients will receive the combination therapy including ablation and life information rehabilitation therapy. The ablation therapy (e.g. cryosurgery or irreversible electroporation) will be performed first for big tumors (> 2 cm), then "Qilisheng" Immunoregulatory Oral Solution will be provided for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
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).
Outcomes
Primary Outcome Measures
Relief degree of tumors
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Secondary Outcome Measures
Progress free survival（PFS）
The duration between treatment and cancer recurrence
Overall survival（OS）
The duration between treatment and patient pass away
Full Information
NCT ID
NCT03239158
First Posted
August 1, 2017
Last Updated
January 23, 2019
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Shengxin Biotechnology Institute, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT03239158
Brief Title
Bioinformation Therapy for Liver Cancer
Official Title
Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Liver Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2, 2017 (Actual)
Primary Completion Date
September 2, 2018 (Actual)
Study Completion Date
September 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Shengxin Biotechnology Institute, Beijing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable liver cancer.
Detailed Description
By enrolling patients with unresectable liver 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver, Cancer of, Non-Resectable
Keywords
Cancer ablation, Life information rehabilitation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cancer ablation
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Life information rehabilitation therapy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Combination therapy
Arm Type
Experimental
Arm Description
In this group, the patients will receive the combination therapy including ablation and life information rehabilitation therapy. The ablation therapy (e.g. cryosurgery or irreversible electroporation) will be performed first for big tumors (> 2 cm), then "Qilisheng" Immunoregulatory Oral Solution will be provided for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Cancer ablation
Other Intervention Name(s)
Cryoablation or irreversible electroporation
Intervention Description
Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.
Intervention Type
Drug
Intervention Name(s)
Life information rehabilitation therapy
Other Intervention Name(s)
"Qilisheng" Immunoregulatory Oral Solution
Intervention Description
Each treatment: one bottle solution each day, consecutive 3 months, oral administration
Primary Outcome Measure Information:
Title
Relief degree of tumors
Description
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Progress free survival（PFS）
Description
The duration between treatment and cancer recurrence
Time Frame
1 year
Title
Overall survival（OS）
Description
The duration between treatment and patient pass away
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fuda cancer institute of Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510665
Country
China
12. IPD Sharing Statement
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Bioinformation Therapy for Liver Cancer
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