- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03350490
Bioinformation Therapy for Intestinal Cancer
January 23, 2019 updated by: Fuda Cancer Hospital, Guangzhou
Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Intestinal Cancer
The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable intestinal cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
By enrolling patients with unresectable intestinal 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).
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510665
- Fuda cancer institute of Fuda cancer hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 :3 - 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cancer ablation
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).
|
Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.
Other Names:
|
Active Comparator: Life information rehabilitation therapy
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).
|
Each treatment: one bottle solution each day, consecutive 3 months, oral administration
Other Names:
|
No Intervention: Control
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).
|
|
Experimental: Combination therapy
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(>2cm),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).
|
Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.
Other Names:
Each treatment: one bottle solution each day, consecutive 3 months, oral administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relief degree of tumors
Time Frame: 3 months
|
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)
Time Frame: 1 year
|
The duration between treatment and cancer recurrence
|
1 year
|
Overall survival(OS)
Time Frame: 3 years
|
The duration between treatment and patient pass way
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2017
Primary Completion (Actual)
November 30, 2018
Study Completion (Actual)
November 30, 2018
Study Registration Dates
First Submitted
November 19, 2017
First Submitted That Met QC Criteria
November 21, 2017
First Posted (Actual)
November 22, 2017
Study Record Updates
Last Update Posted (Actual)
January 25, 2019
Last Update Submitted That Met QC Criteria
January 23, 2019
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bioinformation-intestinal
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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