Mix Vaccine for Metastatic Kidney Cancer

F

Fuda Cancer Hospital, Guangzhou

Status and phase

Completed
Phase 2
Phase 1

Conditions

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

Treatments

Biological: Mix vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT03357289
kidney cancer MV

Details and patient eligibility

About

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

Full description

By enrolling patients with small metastases of kidney cancer 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).

Enrollment

30 patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Mix vaccine
Experimental group
Description:
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).
Treatment:
Biological: Mix vaccine
Control
No Intervention group
Description:
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).

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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