Mix Vaccine for Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is the safety and efficacy of mix vaccine to small metastases of colorectal cancer.

Detailed Description
-----------------
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).

Official Title
-----------------
Safety and Efficacy Study of Mix Vaccine in Colorectal Cancer Patient

Conditions
-----------------
Metastatic Colorectal Cancer, Reaction - Mixed Vaccine

Intervention / Treatment
-----------------
* Biological: Mix vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mix vaccine<br>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). | Biological: Mix vaccine<br>* Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle<br>* Other names: Active immunotherapy for cancer;|
| No Intervention: Control<br>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). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief degree of tumors | It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST） | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival（PFS） | The duration from the beginning of treatment to cancer recurrence or progression | 1 year | 
| Overall survival（OS） | The duration from the beginning of treatment to patient death | 3 years |