Mix Vaccine for Metastatic Colorectal Cancer

NCT ID: NCT03357276

Last Updated: 2019-09-12

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

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2019-08-30

Brief Summary

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The aim of this study is the safety and efficacy of mix vaccine to small metastases of colorectal cancer.

Detailed Description

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By enrolling patients with small metastases of colorectal cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of mix vaccine.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Conditions

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Metastatic Colorectal Cancer Reaction - Mixed Vaccine

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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Mix vaccine

In this group, the patients will receive mix vaccine. The check indexes are image examination (CT, MRI or PET scan) and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Group Type EXPERIMENTAL

Mix vaccine

Intervention Type BIOLOGICAL

Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle

Control

In this group, the patients will receive no special treatment and as a control group. The check indexes are image examination (CT, MRI or PET scan) and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mix vaccine

Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle

Intervention Type BIOLOGICAL

Other Intervention Names

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Active immunotherapy for cancer

Eligibility Criteria

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Inclusion Criteria

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum 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

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinan University Guangzhou

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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colorectal cancer MV

Identifier Type: -

Identifier Source: org_study_id

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