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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02632188
• Other study ID #: EHBHKY2015-02-005
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 10, 2015
• Last updated: December 30, 2015
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: September 2015
• Source: Second Military Medical University
• Contact: Qijun Qian, PHD
• Phone: +86-21-65580677
• Email: qianqj[@]sino-gene.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

A total of 60 patients may be enrolled over a period of 1-2 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 18~65 years old, male or female

2. Signed informed consent

3. Diagnosis of hepatocellular carcinoma (HCC), radical surgery was performed

4. The recurrence of HCC was not found after the Operation and no other immunotherapy was carried out

5. The Eastern Cooperative Oncology Group (ECOG) score =2

6. Child-Pugh score of liver function = 9

7. Routine blood meets the requirements

Exclusion Criteria:

1. Expected Overall survival < 3 months

2. Radical surgery was not performed or recurrence was found after operation

3. Liver function is Childs Pugh C

4. Had received other immunotherapy

5. Other serious diseases:the heart,lung, kidney,digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.

6. Unable or unwilling to provide informed consent, or fail to comply with the test requirements

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Eastern Hepatobiliary Surgery Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Second Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress-free survival		2 years	No
Secondary	Overall survival		2 years	No
Secondary	Quality of life	Quality of life core questionnaire will be used.	2 years	No