Safety and Efficacy of an Anticancer Medication Combined With Immune Cells in Subjects With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03472352|
Recruitment Status : Not yet recruiting
First Posted : March 21, 2018
Last Update Posted : March 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Biological: An anticancer medication (A01) and immune cells (IC01)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Combination Study to Evaluate the Safety and Efficacy of an Anti-cancer Medication (A01) With Immune Cells (IC01) in Subjects With Advanced Solid Tumors|
|Estimated Study Start Date :||April 2018|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: Single Arm
The subjects will be given an anticancer medication (A01) and immune cells (IC01).
Biological: An anticancer medication (A01) and immune cells (IC01)
The administration of A01 and IC01 will be performed in the Second People's Hospital of Yibin, Sichuan, China. The subjects will be observed for any side effects during this time and all the adverse events will be recorded.
- The adverse events associated with infusion of the anticancer medication or the immune cells will be assessed. [ Time Frame: Day 0 to 4 months after the end of the study ]Incidence and duration of all the adverse events will be recorded. The severity of adverse events will be evaluated according to NCI-CTCAE v4.03 criteria.
- Tumor Response of the treatment in patients with advanced solid tumors. [ Time Frame: Before treatment and Day 28 to 4 months after the end of the treatment ]Response Evaluation Criteria in Solid Tumors (RECIST) from the NCI will be used for assessment of radiographic response.
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): NCT03472352
|Contact: Lin Chen, PhD||+86 firstname.lastname@example.org|