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NCT06504901

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Tislelizumab

Tislelizumab 200mg ivd D1

DRUG

Interleukin-2

Interleukin 2 100IU HD,QOD d1-d14

DRUG

Capecitabine

Capecitabine: 1000mg/m2 bid po, d1-d14

DRUG

Oxaliplatin

Oxaliplatin 130mg/m2 ivd, d1

DRUG

Neupogen

rhG-CSF 5mcg/kg HD, QD d1-d14