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Trial record 25 of 77070 for:    Neoplasms

Bioinformation Therapy for Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03239184
Recruitment Status : Completed
First Posted : August 3, 2017
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
Shengxin Biotechnology Institute, Beijing
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Brief Summary:
The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable pancreatic cancer.

Condition or disease Intervention/treatment Phase
Unresectable Pancreatic Cancer Device: Cancer ablation Drug: Life information rehabilitation therapy Phase 2 Phase 3

Detailed Description:
By enrolling patients with unresectable pancreatic 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Pancreatic Cancer
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: "Qilisheng" Immunoregulatory Oral Solution

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
Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound
Other Name: Cryoablation or irreversible electroporation

Drug: Life information rehabilitation therapy
Each treatment: one bottle solution each day, consecutive 3 months, oral administration
Other Name: "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).



Primary Outcome Measures :
  1. Relief degree of tumors [ Time Frame: 3 months ]
    It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)


Secondary Outcome Measures :
  1. Progress free survival(PFS) [ Time Frame: 1 year ]
    The duration between treatment and cancer recurrence

  2. Overall survival(OS) [ Time Frame: 3 years ]
    The duration between treatment and patient pass away



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 > 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239184


Locations
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China, Guangdong
Fuda cancer institute of Fuda cancer hospital
Guangzhou, Guangdong, China, 510665
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Shengxin Biotechnology Institute, Beijing

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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT03239184     History of Changes
Other Study ID Numbers: Bioinformation-panc
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Fuda Cancer Hospital, Guangzhou:
Cancer ablation
Life information rehabilitation therapy

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pharmaceutical Solutions