Immunotherapy Using Pluripotent Killer-Human Epidermal Growth Factor Receptor-2 (PIK-HER2) Cells for the Treatment of Advanced Gastric Cancer With Liver Metastasis

Phase 1

• Conditions: Liver Metastasis; Gastric Cancer
• Interventions: Biological: PIK-HER2; Biological: DC-PMAT

• Registration Number: NCT02632201
• Lead Sponsor: Second Military Medical University

Brief Summary

Objectives:

The purpose of this study is to evaluate the safety and efficacy of PIK-HER2 cells in the treatment of advanced Her2 high expressed gastric cancer with liver metastasis patients.

Methods:

This study designs a novel therapy using PIK-HER2 cells. 40 Her2 positive patients with liver metastasis from gastric cancer will be enrolled. They are randomly divided into dendritic cell-precision multiple antigen T cells (DC-PMAT) group and PIK-HER2 cells group. Both DC-PMAT treatment and PIK-HER2 cells treatment will be performed every 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.

Detailed Description

A total of 40 patients may be enrolled over a period of 1-2 years.

Study Timeline

• Status Verified: 2015-09
• Study Start: 2015-09
• Study First Submitted: 2015-12-13
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-16
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2016-01-01
• Primary Completion: 2017-03
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age 18~65 years old, male or female
2. Life expectancy > 6 months
3. Eastern Cooperative Oncology Group (ECOG) score: 0-2
4. The stomach or gastroesophageal junction carcinoma with hepatic metastasis
5. Adenocarcinoma
6. The expression of HER2 in immunohistochemical tumor tissue should be greater than or equal to 2 levels
7. Creatinine is less than 2.5mg/dL; alanine aminotransferase (ALT) / aspartate aminotransferase(AST)T less than 3 times of the normal; bilirubin is less than 3mg/dL
8. Blood routine conforms to the requirements of the blood sampling
9. Signed informed consent
10. Patients with fertility are willing to use contraceptive method.

Exclusion Criteria

1. Expected Overall survival < 6 months
2. Other serious diseases:the heart,lung,kidney, digestive, nervous, mental disorders, immune regulatory diseases,metabolic diseases, infectious diseases, Etc.
3. Serum creatinine > 2.5mg/dL;Serum Glutamic Oxaloacetic Transaminase (SGOT) > 5 times of the normal;total bilirubin > 100μmol/L
4. Without signed informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PIK-HER2 cells	PIK-HER2	PIK-HER2 cells treatment will be performed every 3 weeks with a total of three periods.
DC-PMAT	DC-PMAT	DC-PMAT treatment will be performed every 3 weeks with a total of three periods.

Primary Outcome Measures

Name	Time	Method
Overall survival	2 years

Secondary Outcome Measures

Name	Time	Method
Progress-free survival	2 years
Quality of life	2 years	Quality of life core questionnaire will be used.

Trial Locations

Locations (1)

Eastern Hepatobiliary Surgery Hospital; 🇨🇳 Shanghai, China