Combination of Cryosurgery and NK Immunotherapy for Advan... | NCT02843581

Studies
Combination of Cryosurgery and NK Immunotherapy for Advanced Esophageal Cancer

NCT02843581

Sponsor

Fuda Cancer Hospital, Guangzhou

Status

Completed

Last Update Posted

Sep 12, 2019Actual

Enrollment

60Actual

Phase

Phase 1Phase 2

Conditions

Metastatic Esophageal Cancer

Interventions

Cryosurgery
NK immunotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2016Actual

Primary Completion Date

Jul 1, 2017Actual

Completion Date

Jul 1, 2019Actual

First Submitted Date

Jul 16, 2016

First Submission Date that Met QC Criteria

Jul 21, 2016

First Posted Date

Jul 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2019

Last Update Posted Date

Sep 12, 2019Actual

Name	Class
Shenzhen Hank Bioengineering Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cryosurgery and NK immunotherapy	Experimental	We use comprehensive cryosurgery to destroy big tumors, and use multiple (more than 6 times) NK immunotherapy to destroy small tumors	Device: Cryosurgery Biological: NK immunotherapy
Cryosurgery	Active Comparator	We use comprehensive cryosurgery to destroy big tumors	Device: Cryosurgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cryosurgery	Device	Argon-helium cryosurgical system	Cryosurgery Cryosurgery and NK immunotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relief degree	It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）	3 months

Secondary Outcomes

Measure	Description	Time Frame
Progress free survival（PFS）		1 year
Overall survival（OS）		3 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guifeng Liu, PhD	Fuda Cancer Hospital, Guangzhou	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fuda cancer institute in Fuda cancer hospital		Guangzhou	Guangdong	510000	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003452	Cryosurgery

Ancestor Terms

ID	Term
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided