- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02849353
Combination of Cryosurgey and NK Immunotherapy for Recurrent Ovarian Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510665
- Fuda cancer institute of Fuda cancer hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cryosurgery and 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).
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Percutaneous ablation under CT or ultrasound guidance
Other Names:
Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
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ACTIVE_COMPARATOR: 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).
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Percutaneous ablation under CT or ultrasound guidance
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relief degree of tumors
Time Frame: 3 months
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It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progress free survival(PFS)
Time Frame: 1 year
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1 year
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Overall survival(OS)
Time Frame: 3 years
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3 years
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- NK-ovary
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedPseudomyxoma Peritonei | Recurrent Endometrial Carcinoma | Ovarian Sarcoma | Recurrent Uterine Sarcoma | Leydig Cell Tumor | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Ovarian Stromal Cancer | Recurrent Ovarian Germ Cell Tumor | Recurrent Fallopian Tube Cancer | Recurrent... and other conditionsUnited States
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Dana-Farber Cancer InstituteAstraZenecaTerminatedRecurrent Ovarian Carcinoma | Recurrent Cervical Carcinoma | Recurrent Endometrial Cancer | Metastatic Endometrial Cancer | Metastatic Cervical Cancer | Recurrent Vaginal Cancer | Recurrent Vulvar Cancer | Metastatic Ovarian Cancer | Recurrent Gynecological Cancer | Metastatic Vaginal Cancer | Metastatic...United States
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National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Cervical Cancer | Recurrent Vaginal Cancer | Recurrent Vulvar Cancer | Stage III Vaginal Cancer | Stage IVA Cervical Cancer | Stage IVA Vaginal Cancer | Stage IVB Cervical Cancer | Stage IVB Vaginal Cancer | Stage IIIA Ovarian... and other conditionsUnited States
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Roswell Park Cancer InstituteEisai Inc.CompletedRecurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube CancerUnited States
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