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Evaluation of Efficacy and Safety of PD-1 Monoclonal Antibody in Combination With rhG-CSF, IL-2, and CapeOX in Initially Resectable Synchronous Colorectal Liver Metastases
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Summary
This study attempts to employ a combination therapy using rhG-CSF, IL-2, and PD-1 inhibitors, aiming to overcome the limitations of monotherapy in immunotherapy through multi-faceted immune regulation. By modulating the immune microenvironment to enhance immune cell infiltration, and breaking through the physical and immunosuppressive barriers of tumors, it seeks to augment the efficacy of immunotherapy. This approach explores the effectiveness of a neoadjuvant treatment model in cases of liver metastasis.
Official title: Evaluation of Efficacy and Safety of PD-1 Monoclonal Antibody in Combination With rhG-CSF, IL-2, and CapeOX in Initially Resectable Synchronous Colorectal Liver Metastases: A Single-Center, Single-Arm, Open-Label Clinical Study (PRICE)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2024-07-10
Completion Date
2027-07-10
Last Updated
2024-07-17
Healthy Volunteers
No
Conditions
Interventions
Tislelizumab
Tislelizumab 200mg ivd D1
Interleukin-2
Interleukin 2 100IU HD,QOD d1-d14
Capecitabine
Capecitabine: 1000mg/m2 bid po, d1-d14
Oxaliplatin
Oxaliplatin 130mg/m2 ivd, d1
Neupogen
rhG-CSF 5mcg/kg HD, QD d1-d14