- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02843581
Combination of Cryosurgery and NK Immunotherapy for Advanced Esophageal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
By enrolling patients with pancreatic 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 nature killer (NK) cells for advanced esophageal cancer.
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
-
-
Guangdong
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Guangzhou, Guangdong, China, 510000
- Fuda cancer institute in 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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cryosurgery and NK immunotherapy
We use comprehensive cryosurgery to destroy big tumors, and use multiple (more than 6 times) NK immunotherapy to destroy small tumors
|
Argon-helium cryosurgical system
Nutral killer cell immunotherapy for more than 6 times
|
Active Comparator: Cryosurgery
We use comprehensive cryosurgery to destroy big tumors
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Argon-helium cryosurgical system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relief degree
Time Frame: 3 months
|
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
|
1 year
|
Overall survival(OS)
Time Frame: 3 years
|
3 years
|
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
Other Study ID Numbers
- NK-esopha
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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