A Phase 1/2 interventional study of Cryosurgery and NK immunotherapy in Recurrent Ovarian Cancer, sponsored by Fuda Cancer Hospital, Guangzhou. Completed at 1 site in China. Open to female participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-12.
Sponsored by Fuda Cancer Hospital, Guangzhou · Phase 1/2, Interventional, and Treatment
The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent ovarian cancer.
By enrolling patients with recurrent ovarian 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).
2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.
This study's enrollment of 30 is below the median of 59 across 2,075 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Fuda Cancer Hospital, Guangzhou is the lead sponsor of 116 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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).
Device: Cryosurgery · Biological: NK immunotherapy
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).
Device: Cryosurgery
Percutaneous ablation under CT or ultrasound guidance
Also known as: Argon-helium cryosurgical system
Each treatment: 8\~10 billion cells in all, transfuion in 3 times, i.v.
Relief degree of tumors
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Time frame: 3 months
Progress free survival（PFS）
Time frame: 1 year
Overall survival（OS）
Time frame: 3 years
Ran from Jul 2016 to primary completion in Jul 2017, 12 months.
Of 53 non-industry phase 1/2 interventional studies under Ovarian Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 110. This study's 12 months is below that.
Counting every sponsor, half of 147 studies reached it within 61 months; a quarter within 44 and three quarters within 110.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Natural Killer Cell
Fuda Cancer Hospital, Guangzhou →