Trial | NCT02849366  Report issue

Title

Combination of Cryosurgery and NK Immunotherapy for Recurrent Sarcoma

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent sarcoma.
By enrolling patients with recurrent sarcoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and natural killer (NK) cells.

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 Started
Jul 01
2016
Primary Completion
Jul 01
2017
Study Completion
Jul 01
2019
Last Update
Sep 12
2019

Device Cryosurgery

Percutaneous ablation under CT or ultrasound guidance

  • Other names: Argon-helium cryosurgical system

Biological NK immunotherapy

Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.

Cryosurgery and NK immunotherapy Experimental

In this group, the patients will receive comprehensive cryosurgery to clear all big tumors and then receive multiple NK immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Cryosurgery Active Comparator

In this group, the patients will receive comprehensive cryosurgery to clear all big tumors. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Criteria 

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 < 5 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
No Results Posted