Mix Vaccine for Metastatic Sarcoma Patients

Fuda Cancer Hospital, Guangzhou30 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Sarcoma Reaction - Mixed Vaccine

Interventions

Mix vaccineBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Fuda cancer institute of Fuda cancer hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Relief degree of tumors

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

Time frame: 3 months

Secondary Outcomes

Progress free survival（PFS）

The duration from the beginning of treatment to cancer recurrence or progression

Time frame: 1 year

Overall survival（OS）

The duration from the beginning of treatment to patient death

Time frame: 3 years

Data from ClinicalTrials.gov

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