Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatocellular Carcinoma | Biological: iNKT cells Drug: Cyclophosphamide Drug: Human recombinated Interleukin-2 Procedure: TACE | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 144 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Study of Adoptive Transfer of Invariant Natural Killer T Cells Combined With Transcatheter Arterial Chemoembolization (TACE) to Treat Advanced Hepatocellular Carcinoma (HCC): Phase II Clinical Trial |
Actual Study Start Date : | March 1, 2019 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: TACE+iNKT for unresectable HCC
TACE combined with autologous iNKT cells infusion will be applied for patients in experimental group. TACE will be performed at 0th and 4th week. 5×10^8-10^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 8th and 12th week.
|
Biological: iNKT cells
5×10^8-10^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 8th and 12th week.
Other Name: invariant Natural Killer T cells
Drug: Cyclophosphamide CTX will be administered intravenously at a dose of 750mg/m2 2 days before the first iNKT cells infusion.
Other Name: CTX
Drug: Human recombinated Interleukin-2 IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days after iNKT cells infusion.
Other Name: IL-2
Procedure: TACE TACE will be conducted to all patients at 0th week and 4th week.
Other Name: Transcatheter Arterial Chemoembolization
|
TACE for unresectable HCC
TACE will be conducted at 0th week and 4th week.
|
Procedure: TACE
TACE will be conducted to all patients at 0th week and 4th week.
Other Name: Transcatheter Arterial Chemoembolization
|
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jun Lu, Director | 86-13661381489 | lujun98@ccmu.edu.cn | |
Contact: Jia Guo, Clinician | 86-18612238992 | 15210775497@163.com |
China, Beijing | |
Beijing Youan Hospital,Capital Medical University | Recruiting |
Beijing, Beijing, China, 100069 | |
Contact: Xuli Bao, Clinician 86-13161935299 bxli2001@163.com |
Study Chair: | Jun Lu, Director | Beijing YouAn Hospital |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | July 3, 2019 | ||||||||
First Posted Date ICMJE | July 8, 2019 | ||||||||
Last Update Posted Date | July 8, 2019 | ||||||||
Actual Study Start Date ICMJE | March 1, 2019 | ||||||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
|
||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Study of Adoptive Transfer of iNKT Cells Combined With TACE to Treat Advanced HCC | ||||||||
Official Title ICMJE | Study of Adoptive Transfer of Invariant Natural Killer T Cells Combined With Transcatheter Arterial Chemoembolization (TACE) to Treat Advanced Hepatocellular Carcinoma (HCC): Phase II Clinical Trial | ||||||||
Brief Summary | Hepatocellular carcinoma (HCC) is a common disease with high mortality. More than 80% patients are first diagnosed with late-stage and unresectable, their effective drugs and treatments are very limited. invariant Natural Killer T (iNKT) cell exhibit antitumor activity against malignant tumors through producing high levels of cytokines. iNKT cells are abundant in the liver, but defect in liver cancer development. iNKT cells can express homing receptors licensing them specifically to migrate liver, then play key antitumor immunity. We already did a phase I study of autologous infusion of iNKT cells in the treatment of patients with advanced HCC. Safety and feasibility of iNKT infusion was proved. The purpose of this study is to verify the effectiveness of iNKT cells infusion combined with transcatheter arterial chemoembolization (TACE) in treatment of advanced HCC. | ||||||||
Detailed Description | Patients with advanced HCC will be enrolled and divided into two groups. Patients in experimental group will be treated with TACE combined with iNKT cells infusion. TACE will be performed at 0th and 4th week. iNKT cells will be infused at 1st, 3rd, 5th, 7th, 8th and 12th week. Patients in control group will be treated with TACE at 0th and 4th week. Adverse events(AEs), overall survival (OS) time and recurrence-free survival (RFS) time, change of immune cells will be monitored. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 Phase 3 |
||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
Condition ICMJE | Hepatocellular Carcinoma | ||||||||
Intervention ICMJE |
|
||||||||
Study Arms ICMJE |
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
144 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender ICMJE |
|
||||||||
Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
|
||||||||
Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04011033 | ||||||||
Other Study ID Numbers ICMJE | Beijing Youan Ethics[2019]034 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement ICMJE |
|
||||||||
Responsible Party | LU JUN, Beijing YouAn Hospital | ||||||||
Study Sponsor ICMJE | Beijing YouAn Hospital | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
|
||||||||
PRS Account | Beijing YouAn Hospital | ||||||||
Verification Date | July 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |