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OpenTrials
Completed

NCT Number: NCT02857920

Combination of Bevacizumab and Allogeneic NK Immunotherapy for Metastatic Solid Tumors

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.

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Key information

Conditions

Malignant Solid Tumour

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fuda cancer institute of Fuda cancer hospital

Guangzhou, Guangdong, 510665, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

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

Other names: Anti-VEGF, Avastin

NK immunotherapy

Biological

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

Primary outcomes

  1. PFS

    Time frame: 1 year

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

  2. OS

    Time frame: 3 years

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

Secondary outcomes

  1. Tumor size

    Time frame: 3 months

    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).

  2. CTC

    Time frame: 3 months

    The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.

  3. PD-1

    Time frame: 3 months

    Peripheral blood (6 mL) was obtained from healthy donors and patients before treatment and 90 days after treatment for the detection of PD-1

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Collaborators

  • Shenzhen Hank Bioengineering Institute

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Aug 5, 2016
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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