Bioinformation Therapy for Pancreatic Cancer

NCT ID: NCT03239184

Last Updated: 2019-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-09-01

Brief Summary

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

Detailed Description

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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).

Conditions

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Unresectable Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Cancer ablation

Intervention Type DEVICE

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

Life information rehabilitation therapy

Intervention Type DRUG

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

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type ACTIVE_COMPARATOR

Cancer ablation

Intervention Type DEVICE

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

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).

Group Type ACTIVE_COMPARATOR

Life information rehabilitation therapy

Intervention Type DRUG

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

Interventions

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Cancer ablation

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

Intervention Type DEVICE

Life information rehabilitation therapy

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

Intervention Type DRUG

Other Intervention Names

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Cryoablation or irreversible electroporation "Qilisheng" Immunoregulatory Oral Solution

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shengxin Biotechnology Institute, Beijing

OTHER

Sponsor Role collaborator

Fuda Cancer Hospital, Guangzhou

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fuda cancer institute of Fuda cancer hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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Bioinformation-panc

Identifier Type: -

Identifier Source: org_study_id

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