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

NCT02638857 | Unknown Phase 1

• 1 other identifier: EHBHKY2015-02-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrence Hepatocellular Carcinoma; Advanced Hepatocellular Carcinoma

Keywords

Recurrence Hepatocellular Carcinoma; Advanced Hepatocellular Carcinoma; Dendritic Cell -Precision Multiple Antigen T Cells; Transcatheter Arterial Chemoembolization

Outcome Measures

Primary Outcomes (1)

• Overall survival

  2 years

Secondary Outcomes (2)

• Progress-free survival

  2 years

• Quality of life

  2 years

Study Arms (2)

Transcatheter Arterial Chemoembolization

SHAM COMPARATOR

Transcatheter Arterial Chemoembolization(TACE) treatment:patients will receive lipiodol,Mitomycin (MMC),Epirubicin（EADM） hepatic arterial infusion,3 cycles.

Procedure: TACE; Drug: lipiodol; Drug: Mitomycin (MMC); Drug: Epirubicin(EADM)

DC-PMAT cells

EXPERIMENTAL

After accepting concurrent TACE treatment,patients will receive 3 cycles of Dendritic Cell -Precision Multiple Antigen T (DC-PMAT) cells treatment.

Procedure: TACE; Biological: Dendritic Cell; Drug: lipiodol; Drug: Mitomycin (MMC); Drug: Epirubicin(EADM); Biological: Precision Multiple Antigen T Cell

Interventions

TACE PROCEDURE

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.

DC-PMAT cells; Transcatheter Arterial Chemoembolization

Dendritic Cell BIOLOGICAL

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.

Also known as: DC

DC-PMAT cells

lipiodol DRUG

lipiodol 10-20ml,hepatic arterial infusion

DC-PMAT cells; Transcatheter Arterial Chemoembolization

Mitomycin (MMC) DRUG

MMC 8～10mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2, hepatic arterial infusion.

DC-PMAT cells; Transcatheter Arterial Chemoembolization

Epirubicin(EADM) DRUG

EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2 hepatic arterial infusion.

DC-PMAT cells; Transcatheter Arterial Chemoembolization

Precision Multiple Antigen T Cell BIOLOGICAL

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.

Also known as: PMAT cell

DC-PMAT cells

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18\~65 years old, male or female
• Signed informed consent
• Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out.
• The recurrence of HCC was found after the operation without distant metastasis.
• The Eastern Cooperative Oncology Group (ECOG) score ≤2
• Child-Pugh score of liver function ≤ 9
• Routine blood meets the requirements.

You may not qualify if:

• Expected Overall survival \< 3 months
• The tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus
• Liver function is Childs Pugh C
• Had received TACE therapy previously or in radiotherapy at present,or taking Sola Feeney
• Other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
• Unable or unwilling to provide informed consent, or fail to comply with the test requirements.

Sponsors & Collaborators

• Second Military Medical University: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, 200438, China

RECRUITING

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MeSH Terms

Interventions

Ethiodized Oil; Mitomycin

Intervention Hierarchy (Ancestors)

Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Feng Shen, PHD

  Eastern Hepatobiliary Surgery Hospital

  STUDY CHAIR

Central Study Contacts

Qijun Qian, PHD

CONTACT

+86-21-65580677; qianqj@sino-gene.cn

Huajun Jin, PHD

CONTACT

+86-21-81875372; hj-jin@Hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 23, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 1, 2016

Record last verified: 2015-09

Locations

CN (1)