Combination of Bevacizumab and Allogeneic NK Immunotherapy for Metastatic Solid Tumors

Malignant Solid Tumour Clinical Trial

Official title:

Combination of Bevacizumab and Allogeneic NK Immunotherapy for Metastatic Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857920
• Other study ID #: NK-Bevacizumab
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 1, 2016
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2018
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is the safety and efficacy of Bevacizumab plus allogeneic natural killer (NK) immunotherapy to many kinds of recurrent solid tumors.

Description:

By enrolling patients with recurrent 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 Bevacizumab and 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Solid Tumour
• Neoplasms

Intervention

Drug:
• Bevacizumab
7.5 mg/kg, i.v, once every 3 weeks (continuous)

Biological:
• NK immunotherapy
Each treatment: 8~10 billion cells in all, transfusion in 3 times, i.v.

Locations

Country	Name	City	State
China	Fuda cancer institute of Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou	Shenzhen Hank Bioengineering Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	PFS was defined as the interval between treatment initiation and local relapse	1 year
Primary	OS	OS was calculated as the interval from treatment initiation to death.	3 years
Secondary	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).	3 months
Secondary	CTC	The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.	3 months
Secondary	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	3 months