Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer

Phase 1

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

• Registration Number: NCT02873442
• Lead Sponsor: Ningbo Cancer Hospital

Brief Summary

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: 2016-08-15
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07
• Primary Completion: 2018-03
• Study Completion: 2018-08

Recruitment & Eligibility

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

Inclusion Criteria

1. Age 18~65 years old, male or female;
2. Life expectancy≥6 months;
3. ECOG score: 0-3;
4. 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;
5. Enough venous channel, no other contraindications to the separation and collection of white blood cells;
6. 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；
7. Signed informed consent；
8. 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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Precision cells combined with TACE	TACE	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 combined with TACE	Precision Cells	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)

Ningbo No.5 Hospital (Ningbo Cancer Hospital); 🇨🇳 Ningbo, Zhejiang, China