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Combination of Cryosurgery and NK Immunotherapy for Advanced Esophageal Cancer

F

Fuda Cancer Hospital, Guangzhou

Status and phase

Completed
Phase 2
Phase 1

Conditions

Metastatic Esophageal Cancer

Treatments

Device: Cryosurgery
Biological: NK immunotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02843581
NK-esopha

Details and patient eligibility

About

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

Full 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).

Enrollment

60 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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