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Combination of Cryosurgery and NK Immunotherapy for Advanced Esophageal Cancer

Primary Purpose

Metastatic Esophageal Cancer

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Cryosurgery
NK immunotherapy
Sponsored by
Fuda Cancer Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Esophageal Cancer focused on measuring Esophageal Cancer, NK immunotherapy, Safety, Efficacy

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fuda cancer institute in Fuda cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cryosurgery and NK immunotherapy

Cryosurgery

Arm Description

We use comprehensive cryosurgery to destroy big tumors, and use multiple (more than 6 times) NK immunotherapy to destroy small tumors

We use comprehensive cryosurgery to destroy big tumors

Outcomes

Primary Outcome Measures

Relief degree
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

Secondary Outcome Measures

Progress free survival（PFS）
Overall survival（OS）

Full Information

First Posted
July 16, 2016
Last Updated
September 10, 2019
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Shenzhen Hank Bioengineering Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02843581
Brief Title
Combination of Cryosurgery and NK Immunotherapy for Advanced Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Shenzhen Hank Bioengineering Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced esophageal cancer.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Esophageal Cancer
Keywords
Esophageal Cancer, NK immunotherapy, Safety, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryosurgery and NK immunotherapy
Arm Type
Experimental
Arm Description
We use comprehensive cryosurgery to destroy big tumors, and use multiple (more than 6 times) NK immunotherapy to destroy small tumors
Arm Title
Cryosurgery
Arm Type
Active Comparator
Arm Description
We use comprehensive cryosurgery to destroy big tumors
Intervention Type
Device
Intervention Name(s)
Cryosurgery
Intervention Description
Argon-helium cryosurgical system
Intervention Type
Biological
Intervention Name(s)
NK immunotherapy
Intervention Description
Nutral killer cell immunotherapy for more than 6 times
Primary Outcome Measure Information:
Title
Relief degree
Description
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Progress free survival（PFS）
Time Frame
1 year
Title
Overall survival（OS）
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guifeng Liu, PhD
Organizational Affiliation
Fuda Cancer Hospital, Guangzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuda cancer institute in Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Combination of Cryosurgery and NK Immunotherapy for Advanced Esophageal Cancer

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