To evaluate the efficacy, safety of Immuncell-LC in combination with Nivolumab in subjects with advanced gastric cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0005542
- Lead Sponsor
- Yonsei University Health System, Gangnam Severance Hospital
- Brief Summary
The target number of subjects for this study is 20, and according to the monitoring plan, an average of 2 or more subjects must be recruited per month to ensure smooth research progress. However, due to difficulties in recruiting suitable subjects for this study, subject registration was slow. Accordingly, early termination was decided at the discretion of the Investigator.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 4
1) Adult males and females aged 19 years or above
2) Histologically and/or cytologically confirmed unresectable advanced/relapsed gastric adenocarcinoma or gastro-esophageal junction cancer subjects
3) A measurable lesion based on RECIST v1.1
4) The Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1
5) Life expectancy of at least 12 weeks
6) Confirmed adequate hematological, hepatic, renal and coagulation functions
1) Prior treatment with any cell therapy products including but not limited to Immuncell-LC or natural killer (NK) cell therapy products
2) Prior immuno-oncology agents such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, and anti-CTLA-4
3) Hypersensitivity to the active ingredient or excipients of Immuncell-LC or nivolumab
4) Unable to collect autologous blood for production of Immuncell-LC at the judgement of the investigator
5) History of anti-cancer treatment within 2 weeks prior to screening
6) An adverse event (AE) with prior treatments that is not resolved
7) History of immunosuppressive drugs within 2 weeks prior to screening
8) Administration of live vaccines, live attenuated vaccines, or inactivated vaccines within 4 weeks prior to screening
9) Serious medical history confirmed at screening
10) Concomitant diseases at screening that may affect the safety and efficacy assessments during the study at the judgement of the investigator
11) Pregnant or breast-feeding women, or women who intend to become pregnant
12) Received other IP or used an investigational device within 4 weeks prior to screening
Ineligible or unable to participate in the study at the judgement of the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) based on RECIST v1.1
- Secondary Outcome Measures
Name Time Method Overall survival (OS), Progression-free survival (PFS) and Duration of response (DOR) and Disease control rate (DCR) based on RECIST v1.1, ORR and PFS and DOR and DCR based on iRECIST