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

Second Military Medical University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Gastric Cancer; Liver Metastasis

Treatments: Biological: DC-PMAT; Biological: PIK-HER2

Study type: Interventional

Funder types: Other

Identifiers

NCT02632201

EHBHKY2015-02-008

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

PIK-HER2 cells

Experimental group

Description:

PIK-HER2 cells treatment will be performed every 3 weeks with a total of three periods.

Treatment:

Biological: PIK-HER2

DC-PMAT

Active Comparator group

Description:

DC-PMAT treatment will be performed every 3 weeks with a total of three periods.

Treatment:

Biological: DC-PMAT