Combination of Cryosurgey and NK Immunotherapy for Recurrent Cervical Cancer

NCT02849340 — Phase 1 / Phase 2, Completed, 30 participants, Fuda Cancer Hospital, Guangzhou

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Registry	NCT02849340
Status	Completed
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	30 (Actual)
Sponsor	Fuda Cancer Hospital, Guangzhou (Other); collaborators: Shenzhen Hank Bioengineering Institute
Conditions	Recurrent Cervical Cancer
Interventions	Cryosurgery, NK immunotherapy (Device, biological)
Dates	start 2016-07-01, primary completion 2017-07-01, completion 2019-07-01, first posted 2016-07-29, last updated 2019-09-12
Locations	1 site in China

-Summary

The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent cervical cancer.

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+Detailed description

By enrolling patients with recurrent cervical cancer 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).

+Arms and interventions

Arm	Type	Interventions	Description
Cryosurgery and NK immunotherapy	Experimental	Device: Cryosurgery; Biological: NK immunotherapy	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	Device: Cryosurgery	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).

Cryosurgery (Device), also known as Argon-helium cryosurgical system: Percutaneous ablation under CT or ultrasound guidance
NK immunotherapy (Biological): Each treatment: 8\~10 billion cells in all, transfuion in 3 times, i.v.

+Outcome measures

Primary outcomes

Relief degree of tumors [3 months]: It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

Secondary outcomes

Progress free survival（PFS） [1 year]
Overall survival（OS） [3 years]

+Eligibility

Sex: Female, ages: 30 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
Fuda cancer institute of Fuda cancer hospital	Guangzhou, Guangdong	China

+Investigators

Jibing Chen, MD, PhD, Principal investigator, Fuda Cancer Hospital, Guangzhou