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

NCT06504901 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-07-17

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2025-07-10
Completion
2027-07-10

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06504901 on ClinicalTrials.gov