Combination of Bevacizumab and Allogeneic NK Immunotherapy for Metastatic Solid Tumors

Phase 1

Completed

• Conditions: Malignant Solid Tumour
• Interventions: Drug: Bevacizumab; Biological: NK immunotherapy

• Registration Number: NCT02857920
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

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.

Detailed 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-08-01
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-05
• Primary Completion: 2017-08-01
• Status Verified: 2018-08
• Study Completion: 2019-08-01
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bevacizumab and NK immunotherapy	NK immunotherapy	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).
Bevacizumab and NK immunotherapy	Bevacizumab	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).
Bevacizumab	Bevacizumab	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).

Primary Outcome Measures

Name	Time	Method
OS	3 years	OS was calculated as the interval from treatment initiation to death.
PFS	1 year	PFS was defined as the interval between treatment initiation and local relapse

Secondary Outcome Measures

Name	Time	Method
Tumor size	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).
CTC	3 months	The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.
PD-1	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

Trial Locations

Locations (1)

Fuda cancer institute of Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China