NCT02632188

Radical Surgery Followed by Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen for the Treatment of Hepatocellular Carcinoma

A Controlled Clinic Trial to Survey the Outcome of Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen in Treating Patients Underwent Radical Surgery for Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Second Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Objectives: The purpose of this study is to evaluate the safety and efficacy of radical surgery combined with dendritic cell-precision multiple antigen T cells in reducing the recurrence and metastasis of liver cancer Methods: This study designs a novel therapy using dendritic cell-precision multiple antigen T cells. 60 postoperative patients of hepatocellular carcinoma will be enrolled. They are randomly divided into postoperative routine therapy group and dendritic cell-precision multiple antigen T cells combined with postoperative routine therapy group. Dendritic cell-precision multiple antigen T cells treatments 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 60 patients may be enrolled over a period of 1-2 years.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
PROCEDURE	Postoperative routine treatment	Postoperative routine treatment according to the hospitals local routines
BIOLOGICAL	DC-PMAT treatment	Postoperative routine treatment according to the hospitals local routines; DC cell suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PMAT cell suspension (1-6×109 PMAT + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-03-01
• Completion: 2017-09-01
• First posted: 2015-12-16
• Last updated: 2016-01-01

Locations

1 site across 1 country: China