The aim of this study is the safety and efficacy of anti-PD-1 plus NK immunotherapy to multiple solid tumors.
By enrolling patients with solid tumors 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 anti-PD-1 and natural killer (NK) 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
110
Patients received i.v. pembrolizumab (10 mg/kg) on day 1 of a 21-day cycle, until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure
Each treatment: about 10 billion cells in all, infusion in 3 times, i.v.
Cancer Institute in Fuda Cancer Hospital
Guangzhou, Guangdong, China
PFS
PFS was defined as the interval between treatment initiation and local relapse,
Time frame: 2 year
OS
OS was calculated as the interval from treatment initiation to death.
Time frame: 3 years
PD-1
Peripheral blood (6 mL) was obtained from healthy donors and patients before treatment and 90 days after treatment for the detection of PD-1
Time frame: 3 months
Tumor size
The tumor responses of the enrolled patients were assessed by CT in accordance with RECIST v1.1.Institute Common Terminology Criteria for Adverse Events (v4.0).
Time frame: 3 months
CEA
CEA was evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment.
Time frame: 3 months
CTC
The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.
Time frame: 3 months
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