Study of Activated CIK Armed With Bispecific Antibody for Advanced Liver Cancer
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|ClinicalTrials.gov Identifier: NCT03146637|
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : February 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Liver Cancer||Biological: Activated CIK Biological: CIK||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a phase II clinical trial of single-center, randomized (1:1of targeted activation CIK and traditional CIK therapy ).|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||With the method of minimum randomized dynamic random by the interactive network response system (IWRS),Participants were randomly assigned to two groups,receive activated CIK or activated CIK armed with anti-CD3-MUC1/CEA/EpCAM/GPC3 bispecific antibody,every participant has a unique identification number and emergency letter which have the information of group.|
|Official Title:||Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Liver Cancer|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||January 27, 2021|
|Estimated Study Completion Date :||January 28, 2021|
Experimental: Activated CIK armed with bispecific antibody treatment group
CIK cells were activated by bispecific antibody of anti-CD3-MUC1/CEA/EpCAM/GPC3
Biological: Activated CIK
Activated CIK armed with bispecific antibody were infused for 3 days，after 2 days，bispecific antibody was infused separately for 3 days
Active Comparator: Traditional CIK treatment group
CIK cells were not activated
Traditional CIK were infused for 3 days
- OS [ Time Frame: 3 years ]Overrall survival.The time of patient from randomization to death caused by any cause.
- PFS [ Time Frame: 3 years ]Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause.
- TTP [ Time Frame: 1 years ]Time tumor progression.The time of patient from randomization to objective progress of the tumor.
- DCR [ Time Frame: 1 years ]Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease.
- ORR [ Time Frame: 1 years ]Objective response rate.The proportion of patients who had a best response rating of complete response and partial response.
- SRR [ Time Frame: 1 years ]Symptom remission rate. The proportion of symptoms are alleviated in all evaluative cases.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146637
|Contact: Jiamin Cheng, Doctor||+86-10-66933129 ext email@example.com|
|302 Military Hospital of China||Recruiting|
|Beijing, Beijing, China, 100039|
|Contact: Jiamin Cheng, Doctor +86-10-66933129 ext 6030 firstname.lastname@example.org|
|Principal Investigator: Yinying Lu|
|Sub-Investigator: Zhen Zeng|
|Sub-Investigator: Xuechun Lu|
|Sub-Investigator: Jiamin Cheng|
|Sub-Investigator: Zhengcheng Li|
|Sub-Investigator: Jun Hou|
|Sub-Investigator: Ting Zhang|
|Sub-Investigator: Chunping Wang|
|Sub-Investigator: Guanghua Rong|
|Sub-Investigator: Bin Yang|
|Sub-Investigator: Yan Chen|
|Sub-Investigator: Ze Liu|
|Study Director:||Yinying Lu, Doctor||Liver Cancer Diagnosis & Treatment and Research Center of 302 Military Hospital of China|