Study on Pre-Surgery Treatment with Dupilumab and Toripalimab for Colorectal Cancer with Liver Metastases

Sponsor: Dan Feng

Sponsor score: 0

ClinicalTrials ID:NCT07277322

Provider View

This clinical trial is testing the safety and effectiveness of using two immunotherapy drugs, Dupilumab and Toripalimab, before surgery in patients with colorectal cancer that has spread to the liver and can be surgically removed.

Patient Parameters

Program Overview

The purpose of this study is to evaluate if using the immunotherapy drugs Dupilumab and Toripalimab before surgery can safely and effectively treat colorectal cancer that has spread to the liver. The study is divided into two phases: Phase 1b focuses on the safety of the treatment, while Phase 2 assesses how well the treatment works in reducing cancer in the liver before surgery. Participants will receive Dupilumab as an injection and Toripalimab through an IV before their planned surgery. The study may expand to test other drug combinations based on initial results.

Description

This study involves two phases to test the use of Dupilumab and Toripalimab in patients with colorectal cancer that has spread to the liver and can be surgically removed. In Phase 1b, the main goal is to ensure the treatment is safe. In Phase 2, the focus is on how well the treatment works in shrinking the cancer before surgery. Participants will receive Dupilumab as a subcutaneous injection and Toripalimab through an IV. The study may include additional groups to test other drug combinations in the future, depending on the results and new research findings.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with colorectal cancer that is not microsatellite instability-high (non-MSI-H) and has spread to the liver.
  • Liver metastases must be operable, including those present at diagnosis or developed after initial treatment.
  • Must be a candidate for surgery.
  • Aged 18 years or older.
  • Good overall health with a performance status score of 0 or 1.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for 3 months after.
  • Able to understand and sign a consent form.
  • Adequate organ and blood function as determined by specific medical tests.

Exclusion Criteria

  • History of autoimmune disorders, except for certain stable conditions like vitiligo or hypothyroidism.
  • Recent treatment with immunomodulatory drugs or Dupilumab.
  • Prior chemotherapy for colorectal cancer within 3 months before the study.
  • Use of investigational cancer treatments.
  • Uncontrolled illnesses or infections.
  • Pregnant or breastfeeding women.
  • Receiving systemic steroid therapy or other immunosuppressive treatments recently.
  • Active autoimmune diseases requiring treatment in the past year.
  • Other progressing cancers requiring treatment, except for certain stable conditions.
  • HIV positive with detectable viral load or not on stable treatment.
  • Active Hepatitis B or C infections.
  • History of organ or bone marrow transplants.
  • Allergic reactions to protein-based treatments.
  • Any condition that might interfere with the study or is not in the participant's best interest.

Locations

FACILITYZIPCITYSTATE
Icahn School of Medicine at Mount Sinai10029New YorkNew York

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