Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer

Advanced Liver Cancer Clinical Trial

Official title:

Clinical Study Using Precision Cell Immunotherapy Combined With Transcatheter Arterial Chemoembolization in Advanced Liver Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02862613
• Other study ID #: SIMC-20160106
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 8, 2016
• Last updated: September 1, 2016
• Start date: August 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2016
• Source: Shanghai International Medical Center
• Contact: Naiyan Han
• Phone: +86 21 6023 6666
• Email: naiyan.han[@]simcgroup.com
• Is FDA regulated: No
• Health authority: China:Ethics Committee:Shanghai International Medical Center Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Advanced Liver Cancer
• Liver Neoplasms
• Precision Cells
• Transcatheter Arterial Chemoembolization

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.

Biological:
• Precision Cells
DC cell suspension (1×107 DC+ physiological saline + 0.25% human bloodalbumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision cells suspension (1-6×109 Precision cells + physiological saline + 0.25% human bloodalbumin) 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	Shanghai International Medical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai International Medical Center

Country where clinical trial is conducted

China, 

Outcome

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