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CompletedNCT03239158Updated Jan 25, 2019

Bioinformation Therapy for Liver Cancer

A Phase 2/3 interventional study of Cancer ablation and Life information rehabilitation therapy in Liver, Cancer of, Non-Resectable, sponsored by Fuda Cancer Hospital, Guangzhou. Completed at 1 site in China. Open to participants aged 30 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
30 Years to 80 Years
Sex
All
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Study summary

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

Read the detailed description

By enrolling patients with unresectable liver 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).

02

Conditions studied

  • Liver, Cancer of, Non-Resectable

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Keywords

  • Cancer ablation
  • Life information rehabilitation therapy
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In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's enrollment of 120 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Fuda Cancer Hospital, Guangzhou is the lead sponsor of 113 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
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 > 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
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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 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

  • 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 the combination therapy including ablation and life information rehabilitation therapy. The ablation therapy (e.g. cryosurgery or irreversible electroporation) will be performed first for big tumors (\> 2 cm), then "Qilisheng" Immunoregulatory Oral Solution will be provided 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 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).

Interventions

  • DeviceCancer ablation

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

    Also known as: Cryoablation or irreversible electroporation

  • DrugLife information rehabilitation therapy

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

    Also known as: "Qilisheng" Immunoregulatory Oral Solution

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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 treatment and cancer recurrence

    Time frame: 1 year

  2. Overall survival(OS)

    The duration between treatment and patient pass away

    Time frame: 3 years

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Study locations

1 site
  • Fuda cancer institute of Fuda cancer hospital
    Guangzhou, Guangdong 510665, China
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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 ↗
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Registry details

Key details

Study ID
NCT03239158
Lead sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Shengxin Biotechnology Institute, Beijing
Responsible party
Sponsor
First posted
Aug 3, 2017
Start date
Sep 2, 2017
Primary completion
Sep 2, 2018
Completion
Sep 2, 2018
Last update
Jan 25, 2019

Oversight

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

Not currently enrolling

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

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