Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer

NCT02862613 | Unknown Phase 1

• 1 other identifier: SIMC-20160106
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Precision Cells; Transcatheter Arterial Chemoembolization; Advanced Liver Cancer

Keywords

Precision Cells; Transcatheter Arterial Chemoembolization; Advanced Liver Cancer

Outcome Measures

Primary Outcomes (2)

• Overall survival

  2 years

• Progress-free survival

  2 years

Secondary Outcomes (1)

• Quality of life

  2 years

Study Arms (2)

Precision Cells

EXPERIMENTAL

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

Procedure: TACE; Biological: Precision Cells

Transcatheter Arterial Chemoembolization

ACTIVE COMPARATOR

patients will receive MMC,EADM hepatic arterial infusion,6 cycles.

Procedure: TACE

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.

Precision Cells; Transcatheter Arterial Chemoembolization

Precision Cells BIOLOGICAL

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.

Precision 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;
• 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.

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

• Shanghai International Medical Center: lead

Study Sites (1)

Shanghai International Medical Center

Shanghai, Shanghai Municipality, 201318, China

RECRUITING

Study Officials

• Naiyan Han

  Shanghai International Medical Center

  STUDY CHAIR

Central Study Contacts

Naiyan Han

CONTACT

+86 21 6023 6666; naiyan.han@simcgroup.com

Study Design

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

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 11, 2016
• Study Start: August 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 2, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)