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NCT Number: NCT02338778

Safety and Efficacy Study of Mix Vaccine in Hepatocyte Carcinoma Patient

The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV). Enrolled patients will receive standard treatment according to National Comprehensive Cancer Network (NCCN) guide line with or without combining MV injection. The efficacy and side effect will be compared between the two groups.

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Key information

Conditions

Liver Neoplasms Digestive System Diseases Digestive System Neoplasms Liver Diseases Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

About this study

In the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease progression.

Blood sample will be obtained at baseline and every week before MV injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout the study. Side effect, progression free survival, immunology index and general status will be recorded.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with hepatocyte carcinoma based on histology
  • Evaluable lesions on imaging study
  • Without known immunodeficiency
  • Age >18 and <80 years ago

Exclusion criteria

  • Patients is unable or unwilling to sign informed consent
  • Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication
  • Positive HIV and/or RPR (rapid plasma reagin)
  • Female patient who is pregnant or breast feeding
  • Patients, based on the opinion pf the investigator, should not be enrolled into this study
  • Prior anti-cancer vaccine or biological immunotherapy
  • Allergic to any known ingredient of the MV compound

Treatment and study plan

MV

Biological

MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), typhoid, Staphylococcus aureus, paratyphoid A and B. Accessories include microbial A, lecithin, Twain-80, span 20 and soy-bean oil for injection. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.

standard treatment

Other

Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.

Primary outcomes

  1. efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1

    Time frame: 2 years

Secondary outcomes

  1. safety as measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria

    Time frame: 1 month

  2. immunology index

    Time frame: 2 years

    including lymphocyte sub-type number and function, and cytokines

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Registry information

Official study title

Safety Issue and Efficacy Study of Combining Mix Vaccine and Standard Therapy in the Treatment of Hepatocyte Carcinoma Patient

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 14, 2015
Registry last updated
Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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