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Completed

NCT Number: NCT03357315

Mix Vaccine for Metastatic Sarcoma Patients

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

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Key information

Conditions

Metastatic Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Reaction - Mixed Vaccine Sarcoma

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fuda cancer institute of Fuda cancer hospital

Guangzhou, Guangdong, 510665, China

About this study

By enrolling patients with small metastases of sarcoma 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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Mix vaccine

Biological

Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle

Other names: Active immunotherapy for cancer

Primary outcomes

  1. Relief degree of tumors

    Time frame: 3 months

    It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Collaborators

  • Jinan University Guangzhou

Registry information

Official study title

Safety and Efficacy Study of Mix Vaccine in Sarcoma Patient

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 29, 2017
Registry last updated
Sep 12, 2019

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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