High-activity Natural Killer Immunotherapy for Small Metastases of Colorectal Cancer

Fuda Cancer Hospital, Guangzhou20 enrolled

Overview

The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of colorectal cancer.

By enrolling patients with small metastases of colorectal cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells. 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Colorectal Cancer

Interventions

High-activity natural killerBIOLOGICAL

Each treatment: 8\~10 billion cells in all, transfuion in 3 times, i.v.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

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 \< 2 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

Locations (1)

Fuda cancer institute of Fuda cancer hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Relief degree of tumors

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

Time frame: 3 months

Secondary Outcomes

Progress free survival（PFS）

Time frame: 1 year

Overall survival（OS）

Time frame: 3 years

Data from ClinicalTrials.gov

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