Fuda cancer institute of Fuda cancer hospital
Guangzhou, Guangdong, 510665, China
Completed
NCT Number: NCT03350490
Bioinformation Therapy for Intestinal Cancer
The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable intestinal cancer.
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Conditions
Age range
20 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
About this study
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).
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 ：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
Treatment and study plan
Cancer ablation
DeviceTumors 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
DrugEach treatment: one bottle solution each day, consecutive 3 months, oral administration
Other names: "Qilisheng" Immunoregulatory Oral Solution
Primary outcomes
-
Relief degree of tumors
Time frame: 3 months
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Secondary outcomes
-
Progress free survival（PFS）
Time frame: 1 year
The duration between treatment and cancer recurrence
-
Overall survival（OS）
Time frame: 3 years
The duration between treatment and patient pass way
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 Intestinal Cancer
Important dates
- Study start
- 2017
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Nov 22, 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.