Mix Vaccine for Metastatic Sarcoma Patients

Phase 1

Completed

• Conditions: Metastatic Sarcoma; Reaction - Mixed Vaccine
• Interventions: Biological: Mix vaccine

• Registration Number: NCT03357315
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2017-11-23
• Study First Submitted QC: 2017-11-23
• Study First Posted: 2017-11-29
• Study Start: 2017-11-30
• Status Verified: 2018-11
• Primary Completion: 2018-11-30
• Study Completion: 2019-08-30
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mix vaccine	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival（OS）	3 years	The duration from the beginning of treatment to patient death
Progress free survival（PFS）	1 year	The duration from the beginning of treatment to cancer recurrence or progression

Trial Locations

Locations (1)

Fuda cancer institute of Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China