Combination of Bevacizumab and Allogeneic NK Immunotherapy for Metastatic Solid Tumors

NCT02857920 | Completed Phase 1

• 1 other identifier: NK-Bevacizumab
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Solid Tumour

Keywords

Vascular Endothelial Growth Factor (VEGF) antibody; solid tumor; NK Immunotherapy

Outcome Measures

Primary Outcomes (2)

• PFS

  PFS was defined as the interval between treatment initiation and local relapse

  1 year

• OS

  OS was calculated as the interval from treatment initiation to death.

  3 years

Secondary Outcomes (3)

• Tumor size

  3 months

• CTC

  3 months

• PD-1

  3 months

Study Arms (2)

Bevacizumab and NK immunotherapy

EXPERIMENTAL

In this group, the patients will receive regular Bevacizumab treatment in combination with multiple NK immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Drug: Bevacizumab; Biological: NK immunotherapy

Bevacizumab

ACTIVE COMPARATOR

In this group, the patients will receive regular Bevacizumab treatment to control the tumor growth. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

7.5 mg/kg, i.v, once every 3 weeks (continuous)

Also known as: Anti-VEGF, Avastin

Bevacizumab; Bevacizumab and NK immunotherapy

NK immunotherapy BIOLOGICAL

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

Bevacizumab and NK immunotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with cardiac pacemaker
• Patients with brain metastasis
• Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead
• Shenzhen Hank Bioengineering Institute: collaborator

Study Sites (1)

Fuda cancer institute of Fuda cancer hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jibing Chen, MD, PhD

  Fuda Cancer Hospital, Guangzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 5, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2019
• Last Updated: September 14, 2020

Record last verified: 2018-08

Locations

CN (1)