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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02632188

Enrollment

Registered

2015-12-16

Start date

2015-09-30

Completion date

2017-09-30

Last updated

2016-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

Keywords

Recurrence, Metastasis, liver cancer

Brief 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.

Interventions

PROCEDUREPostoperative routine treatment

Postoperative routine treatment according to the hospitals local routines

BIOLOGICALDC-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progress-free survival	2 years

Secondary

Measure	Time frame	Description
Overall survival	2 years	—
Quality of life	2 years	Quality of life core questionnaire will be used.

Countries

China

Contacts

Primary ContactQijun Qian, PHD

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

Backup ContactHuajun Jin, PHD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026