Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer

Phase 1

• Conditions: Precision Cells; Transcatheter Arterial Chemoembolization; Advanced Liver Cancer
• Interventions: Procedure: TACE; Biological: Precision Cells

• Registration Number: NCT02862613
• Lead Sponsor: Shanghai International Medical Center

Brief Summary

Objectives:

To evaluate the safety and effectiveness of cell therapy using Precision Cells Combined With TACE in Advanced Liver Cancer.

Eligibility:

Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Liver Cancer.

Detailed Description

A total of 40 patients may be enrolled over a period of 1-2 years.

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-11
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02
• Primary Completion: 2018-03
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age 18~65 years old, male or female;
• Life expectancy≥6 months;
• ECOG score: 0-3;
• Advanced Malignancies (lung cancer, gastric cancer) were diagnosed by pathological or clinical physicians,and Diagnosis of hepatocellular carcinoma (HCC), surgery can not be performed but TACE treatment can be carried out;
• Enough venous channel, no other contraindications to the separation and collection of white blood cells;
• Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x 10*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level;
• Signed informed consent;
• Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Precision Cells	TACE	Precision Cells combined with Transcatheter Arterial Chemoembolization: Transcatheter Arterial Chemoembolization: patients will receive MMC,EADM hepatic arterial infusion,6 cycles. Precision Cells：After accepting concurrent TACE treatment,patients will receive 3 cycles of Precision Cells treatment
Precision Cells	Precision Cells	Precision Cells combined with Transcatheter Arterial Chemoembolization: Transcatheter Arterial Chemoembolization: patients will receive MMC,EADM hepatic arterial infusion,6 cycles. Precision Cells：After accepting concurrent TACE treatment,patients will receive 3 cycles of Precision Cells treatment
Transcatheter Arterial Chemoembolization	TACE	patients will receive MMC,EADM hepatic arterial infusion,6 cycles.

Primary Outcome Measures

Name	Time	Method
Overall survival	2 years
Progress-free survival	2 years

Secondary Outcome Measures

Name	Time	Method
Quality of life	2 years	Questionnaire will be used.

Trial Locations

Locations (1)

Shanghai International Medical Center; 🇨🇳 Shanghai, Shanghai, China