Mix Vaccine for Metastatic Colorectal 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03357276|
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : November 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer Reaction - Mixed Vaccine||Biological: Mix vaccine||Phase 1 Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Study of Mix Vaccine in Colorectal Cancer Patient|
|Estimated Study Start Date :||November 30, 2017|
|Estimated Primary Completion Date :||November 30, 2018|
|Estimated Study Completion Date :||November 30, 2020|
Experimental: 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).
Biological: Mix vaccine
Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle
Other Name: Active immunotherapy for cancer
No Intervention: 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).
- Relief degree of tumors [ Time Frame: 3 months ]It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
- Progress free survival（PFS） [ Time Frame: 1 year ]The duration from the beginning of treatment to cancer recurrence or progression
- Overall survival（OS） [ Time Frame: 3 years ]The duration from the beginning of treatment to patient death
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): NCT03357276
|Contact: Jibing Chen, MD, PhDemail@example.com|
|Fuda cancer institute of Fuda cancer hospital||Recruiting|
|Guangzhou, Guangdong, China, 510665|
|Contact: Jibing Chen, MD, PhD +86-18903068207 firstname.lastname@example.org|