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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
Sponsor:
Collaborator:
Jinan University Guangzhou
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

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

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Reaction - Mixed Vaccine Biological: Mix vaccine Phase 1 Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).



Primary Outcome Measures :
  1. Relief degree of tumors [ Time Frame: 3 months ]
    It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)


Secondary Outcome Measures :
  1. Progress free survival(PFS) [ Time Frame: 1 year ]
    The duration from the beginning of treatment to cancer recurrence or progression

  2. Overall survival(OS) [ Time Frame: 3 years ]
    The duration from the beginning of treatment to patient death



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Jibing Chen, MD, PhD +86-18903068207 jibingchen398@163.com

Locations
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China, Guangdong
Fuda cancer institute of Fuda cancer hospital Recruiting
Guangzhou, Guangdong, China, 510665
Contact: Jibing Chen, MD, PhD    +86-18903068207    jibingchen398@163.com   
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Jinan University Guangzhou

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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT03357276     History of Changes
Other Study ID Numbers: colorectal cancer MV
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs