Mix Vaccine for Metastatic Colorectal Cancer

Overview

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

Full Title of Study: “Safety and Efficacy Study of Mix Vaccine in Colorectal Cancer Patient”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2018

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).

Interventions

  • Biological: Mix vaccine
    • Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle

Arms, Groups and Cohorts

  • 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).
  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Relief degree of tumors
    • Time Frame: 3 months
    • It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fuda Cancer Hospital, Guangzhou
  • Collaborator
    • Jinan University Guangzhou
  • Provider of Information About this Clinical Study
    • Sponsor

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