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

  • China
    • 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

16 years to 76 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).
Device: Cancer ablation
Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.
Other Names:
  • Cryoablation or irreversible electroporation
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).
Drug: Life information rehabilitation therapy
Each treatment: one bottle solution each day, consecutive 3 months, oral administration
Other Names:
  • "Qilisheng" Immunoregulatory Oral Solution
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).
Device: Cancer ablation
Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.
Other Names:
  • Cryoablation or irreversible electroporation
Drug: Life information rehabilitation therapy
Each treatment: one bottle solution each day, consecutive 3 months, oral administration
Other Names:
  • "Qilisheng" Immunoregulatory Oral Solution

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

Fuda Cancer Hospital, Guangzhou

Collaborators

Shengxin Biotechnology Institute, Beijing

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

Keywords

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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