Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen Combined With Transcatheter Arterial Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma

Advanced Hepatocellular Carcinoma Clinical Trial

Official title:

A Controlled Clinic Trial of Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen in Combination With Transcatheter Arterial Chemoembolization in Treating Patients With Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02638857
• Other study ID #: EHBHKY2015-02-004
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 9, 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 dendritic cell-precision multiple antigen T cells with transcatheter arterial chemoembolization in the treatment of hepatocellular carcinoma.

Methods： This study designs a novel therapy using dendritic cell-precision multiple antigen T cells. 60 patients will be enrolled. They are randomly divided into transcatheter arterial chemoembolization group and dendritic cell-precision multiple antigen T cells combined with transcatheter arterial chemoembolization group. 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), surgery can not be performed but TACE treatment can be carried out.

4. The recurrence of HCC was found after the operation without distant metastasis.

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. The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus

3. Liver function is Childs Pugh C

4. Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney

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

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular
• Recurrence
• Recurrence Hepatocellular Carcinoma

Intervention

Procedure:
• TACE
lipiodol 10-20ml,MMC 8~10mg,EADM20~40mg. According to tumor area of maximum diameter,0.1~0.2ml/cm2 hepatic arterial infusion.Each cycle received one TACE treatment on day 13,34,55.

Biological:
• Dendritic Cell
DC 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.

Drug:
• lipiodol
lipiodol 10-20ml,hepatic arterial infusion
• Mitomycin (MMC)
MMC 8~10mg. According to tumor area of maximum diameter,0.1~0.2ml/cm?2, hepatic arterial infusion.
• Epirubicin(EADM)
EADM20~40mg. According to tumor area of maximum diameter,0.1~0.2ml/cm?2 hepatic arterial infusion.

Biological:
• Precision Multiple Antigen T Cell
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	Overall survival		2 years	No
Secondary	Progress-free survival		2 years	No
Secondary	Quality of life	Quality of life core questionnaire will be used.	2 years	No