Combination of Cryosurgery and NK Immunotherapy for Advanced Esophageal Cancer

Phase 1

Completed

• Conditions: Metastatic Esophageal Cancer
• Interventions: Device: Cryosurgery; Biological: NK immunotherapy

• Registration Number: NCT02843581
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

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).

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-07-16
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-26
• Primary Completion: 2017-07-01
• Status Verified: 2019-07
• Study Completion: 2019-07-01
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival（OS）	3 years
Progress free survival（PFS）	1 year

Trial Locations

Locations (1)

Fuda cancer institute in Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China