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Bioinformation Therapy for Intestinal Cancer

Primary Purpose

Advanced Intestinal Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cancer ablation
Life information rehabilitation therapy
Sponsored by
Fuda Cancer Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Intestinal Cancer focused on measuring Cancer ablation, Life information rehabilitation therapy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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 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).

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 way

Full Information

First Posted
November 19, 2017
Last Updated
January 23, 2019
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Shengxin Biotechnology Institute, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT03350490
Brief Title
Bioinformation Therapy for Intestinal Cancer
Official Title
Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Intestinal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 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 intestinal cancer.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Intestinal Cancer
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 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).
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 way
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 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 ：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
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 Intestinal Cancer

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