A Phase 1/2 interventional study of Mix vaccine in Metastatic Colorectal Cancer and Reaction - Mixed Vaccine, sponsored by Fuda Cancer Hospital, Guangzhou. Completed at 1 site in China. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-12.
Sponsored by Fuda Cancer Hospital, Guangzhou · Phase 1/2, Interventional, and Treatment
The aim of this study is the safety and efficacy of mix vaccine to small metastases of colorectal cancer.
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).
Exclusion Criteria:
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
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).
Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle
Also known as: Active immunotherapy for cancer
Relief degree of tumors
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Time frame: 3 months
Progress free survival（PFS）
The duration from the beginning of treatment to cancer recurrence or progression
Time frame: 1 year
Overall survival（OS）
The duration from the beginning of treatment to patient death
Time frame: 3 years
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Fuda Cancer Hospital, Guangzhou