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 | Not Yet Recruiting DMC

• 1 other identifier: PRICE202407
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Colorectal Cancer

Keywords

Tislelizumab; Interleukin-2; MSS/pMMR colorectal cancer; rhG-CSF

Outcome Measures

Primary Outcomes (1)

• CR rate (cCR + local excision pCR)

  Complete Response rate," which includes both "complete clinical response" (cCR)

  3 years

Secondary Outcomes (2)

• Event-Free Survival rates

  5 years

• Overall Survival rates

  5 years

Study Arms (1)

CapeOX+PD-1+IL-2+rhG-CSF

Tislelizumab 200mg ivd D1 + Interleukin 2 100IU HD,QOD d1-d14+rhG-CSF 5mcg/kg HD, QD d1-d14 +CapeOX (Capecitabine: 1000mg/m2 bid po, d1-d14；Oxaliplatin 130mg/m2 ivd, d1) 6 cycles

Drug: Tislelizumab; Drug: Interleukin-2; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Neupogen

Interventions

Tislelizumab DRUG

Tislelizumab 200mg ivd D1

CapeOX+PD-1+IL-2+rhG-CSF

Interleukin-2 DRUG

Interleukin 2 100IU HD,QOD d1-d14

CapeOX+PD-1+IL-2+rhG-CSF

Capecitabine DRUG

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

CapeOX+PD-1+IL-2+rhG-CSF

Oxaliplatin DRUG

Oxaliplatin 130mg/m2 ivd, d1

CapeOX+PD-1+IL-2+rhG-CSF

Neupogen DRUG

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

CapeOX+PD-1+IL-2+rhG-CSF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. Age ≥18 years and ≤75 years 2. Histologically confirmed colorectal adenocarcinoma 3. pMMR (proficient mismatch repair) or MSI-L (microsatellite instability-low) or MSS (microsatellite stable) 4. Synchronous liver metastases 5. Achievable NED (No Evidence of Disease) status 6. CRS (Clinical Risk Score) of 3-4 points 7. ECOG (Eastern Cooperative Oncology Group) Performance Status score ≤ 1

You may qualify if:

• Age ≥18 years and ≤75 years
• Histologically confirmed colorectal adenocarcinoma
• pMMR (proficient mismatch repair) or MSI-L (microsatellite instability-low) or MSS (microsatellite stable)
• Synchronous liver metastases
• Achievable NED (No Evidence of Disease) status
• CRS (Clinical Risk Score) of 3-4 points
• ECOG (Eastern Cooperative Oncology Group) Performance Status score ≤ 1

You may not qualify if:

• Recurrent colorectal cancer with active bleeding, perforation, or complex conditions requiring urgent surgery; or concurrent non-colorectal cancer malignancies.
• Patients who have previously received systemic anticancer therapy for colorectal cancer; or have been treated with PD-1, PD-L1, or CTLA-4 antibodies.
• Patients with any active autoimmune disease; known or tested positive for Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS); or a history requiring steroid or immunosuppressive drug treatment.
• Patients with interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (such as diabetes, hypertension, pulmonary fibrosis, and acute pneumonia).
• Patients who experienced any Grade 2 or higher toxicities due to prior treatments (as classified by the Common Terminology Criteria for Adverse Events \[CTCAE\] version 5), which have not resolved (excluding anemia, alopecia, and skin pigmentation changes); known or suspected history of hypersensitivity to any of the drugs used in the trial.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

tislelizumab; Interleukin-2; Capecitabine; Oxaliplatin; Filgrastim

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors

Central Study Contacts

Yueming Sun, MD

CONTACT

862568306026; sunyueming@njmu.edu.cn

Yue Wang, MD

CONTACT

862568306026; wangyue@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: July 10, 2024
• Primary Completion: July 10, 2025
• Study Completion (Estimated): July 10, 2027
• Last Updated: July 17, 2024

Record last verified: 2024-07