NCT02843581

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

September 12, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 16, 2016

Last Update Submit

September 10, 2019

Conditions

Metastatic Esophageal Cancer

Keywords

Esophageal CancerNK immunotherapySafetyEfficacy

Outcome Measures

Primary Outcomes (1)

  • Relief degree

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

    3 months

Secondary Outcomes (2)

  • Progress free survival（PFS）

    1 year

  • Overall survival（OS）

    3 years

Study Arms (2)

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: CryosurgeryBiological: NK immunotherapy

Cryosurgery

ACTIVE COMPARATOR

We use comprehensive cryosurgery to destroy big tumors

Device: Cryosurgery

Interventions

CryosurgeryDEVICE

Argon-helium cryosurgical system

CryosurgeryCryosurgery and NK immunotherapy
NK immunotherapyBIOLOGICAL

Nutral killer cell immunotherapy for more than 6 times

Cryosurgery and NK immunotherapy

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with cardiac pacemaker
  • Patients with brain metastasis
  • Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuda cancer institute in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Officials

  • Guifeng Liu, PhD

    Fuda Cancer Hospital, Guangzhou

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2016

First Posted

July 26, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2019

Last Updated

September 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

Locations

CN(1)