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CompletedNCT03350477Updated Jan 25, 2019

Bioinformation Therapy for Gastric Cancer

A Phase 2/3 interventional study of Cancer ablation and Life information rehabilitation therapy in Advanced Gastric Cancer, sponsored by Fuda Cancer Hospital, Guangzhou. Completed at 1 site in China. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-01-25.

Sponsored by Fuda Cancer Hospital, Guangzhou · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable gastric cancer.

Read the detailed description

By enrolling patients with unresectable gastric cancer adapted to enrolled criteria,this study will document for the first time the synergistic effect of cancer according to local relief degree,progress free survival(PFS)and overall survival(OS).

02

Conditions studied

  • Advanced Gastric Cancer

Keywords

  • Cancer ablation
  • Life information rehabilitation therapy
03

In context

Lead sponsor

Fuda Cancer Hospital, Guangzhou is the lead sponsor of 116 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with cardiac pacemaker
  • Patients with brain metastasis
  • Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Cancer ablation

    In this group,the patients will receive ablation therapy(e.g.cryosurgery or irrreversible electroporation) first for big tumors (\>2cm).The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

    Device: Cancer ablation

  • 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

  • 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 · Drug: Life information rehabilitation therapy

  • No intervention
    Control

    In this group,the patients will recieve 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).

Interventions

  • DeviceCancer ablation

    Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.

    Also known as: Cryoblation or irreversible electroporation

  • Each treatment: one bottle solution each day, consecutive 3 months, oral administration

    Also known as: "Qilisheng" Immunoregulatory Oral Solution

06

What researchers measure

Primary outcomes

  1. Relief degree of tumors

    It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)

    Time frame: 3 months

Secondary outcomes

  1. Progress free survival(PFS)

    The duration between treament and cancer recurrence

    Time frame: 1 year

  2. Overall survival

    The duration between treament and patient pass way

    Time frame: 3 years

07

Study locations

1 site
  • Fuda cancer institute of Fuda cancer hospital
    Guangzhou, Guangdong 510665, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03350477
Collaborators
Shengxin Biotechnology Institute, Beijing
Responsible party
Sponsor
First posted
Nov 22, 2017
Start date
Nov 30, 2017
Primary completion
Nov 30, 2018
Completion
Nov 30, 2018
Last update
Jan 25, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Qilisheng Immunoregulatory Oral Solution

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