Trials / Unknown
UnknownNCT03146637
Study of Activated CIK Armed With Bispecific Antibody for Advanced Liver Cancer
Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Liver Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Benhealth Biopharmaceutical (Shenzhen) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase II Randomized comparison clinical trial of activated CIK armed with anti-CD3-MUC1/CEA/EpCAM/GPC3 bispecific antibody for advanced liver cancer. And the aim of this research is to study the clinical efficacy and safety of activated CIK armed with anti-CD3-MUC1/CEA/EpCAM/GPC3 bispecific antibody for liver cancer.
Detailed description
Liver cancer is one of the most common malignancies in China, ranking fourth in all malignant tumors and third in mortality. Immunetherapy is considered to be one of the most promising means of human against cancer. This is a phase II clinical trial of single-center, randomized (1:1of targeted activation CIK and traditional CIK therapy )comparison clinical trial of activated CIK armed with anti-CD3-MUC1/CEA/EpCAM/GPC3 bispecific antibody for advanced liver cancer. The investigators plan to recruit for 80 cases patients with advanced liver cancer, the first 20 cases were directly received treatment of activated CIK, and the cases after the 20th were randomly assigned to two group，one of the two group will receive treatment of traditional CIK, and the other receive activated CIK. The result of this study was statistic and analysed with the record of Response Evaluation Criteria In Solid Tumors(RECIST1.1) evaluation standard.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| BIOLOGICAL | CIK | Traditional CIK were infused for 3 days |
Timeline
- Start date
- 2017-05-01
- Primary completion
- 2021-01-27
- Completion
- 2021-01-28
- First posted
- 2017-05-10
- Last updated
- 2021-02-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03146637. Inclusion in this directory is not an endorsement.