NCT03357289

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

September 12, 2019

Status Verified

November 1, 2018

Enrollment Period

1 year

First QC Date

November 23, 2017

Last Update Submit

September 10, 2019

Conditions

Metastasis From Malignant Tumor of Kidney (Disorder)Reaction - Mixed Vaccine

Outcome Measures

Primary Outcomes (1)

  • Relief degree of tumors

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

    3 months

Secondary Outcomes (2)

  • Progress free survival（PFS）

    1 year

  • Overall survival（OS）

    3 years

Study Arms (2)

Mix vaccine

EXPERIMENTAL

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).

Biological: Mix vaccine

Control

NO INTERVENTION

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).

Interventions

Mix vaccineBIOLOGICAL

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

Also known as: Active immunotherapy for cancer
Mix vaccine

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with cardiac pacemaker
  • Patients with brain metastasis
  • Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer institute of Fuda cancer hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Interventions

Immunotherapy, Active

Intervention Hierarchy (Ancestors)

ImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2017

First Posted

November 29, 2017

Study Start

November 30, 2017

Primary Completion

November 30, 2018

Study Completion

August 30, 2019

Last Updated

September 12, 2019

Record last verified: 2018-11

Locations

CN(1)