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Neoadjuvant Dupilumab and Toripalimab for Colorectal Cancer with Liver Metastases

This study is testing two immunotherapy drugs, dupilumab and toripalimab, in people with colorectal cancer that has spread to the liver (liver metastases) and is considered "microsatellite stable" (MSS CRC). You might be able to join if you have MSS CRC with liver metastases that can be removed by surgery. The main goals are to see how safe the drugs are and how well they work to shrink the cancer before surgery. The study plans to enroll 24 participants. The current status of the study is unclear.

Study design
This is a Phase 1b/2 study, meaning it will first look at safety and then at how well the treatment works. It plans to include 24 participants.
What's involved
You would receive dupilumab as an injection under the skin and toripalimab through an IV before your planned surgery.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured for up to 30 days after your last dose of dupilumab.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07277322

Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases

Recruiting
PHASE1Ages 18+InterventionalTreatment
Dan Feng
~24 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:DupilumabToripalimab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of dose limiting toxicities (DLTs)
Measured over up to 30 days post last administration of study drug dupilumab

Conditions

Metastatic Colorectal Cancer
Liver Metastases

Explore related trials

Colorectal CarcinomaMetastatic Malignant Neoplasm in the LiverMRC1 wt AlleleMSI1 Gene

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Dan Feng, MD, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Thomas Marron, MD, PhD · STUDY_CHAIR · Icahn School of Medicine at Mount Sinai

Who to contact

Lisa Fitzgerald
[email protected]
(917) 748-0962
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

synchronous liver metastases (present at the time of diagnosis of MSS CRC) and treatment-naïve
metachronous liver metastasis (developed after resection of the primary tumor) without prior adjuvant chemotherapy
metachronous liver metastasis (developed after resection of the primary tumor) with adjuvant chemotherapy completed greater than 3 months from the time of consent.
A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Hematologic
Platelets ≥75,000 /mcL
Hemoglobin ≥8 g/dL
Renal\* o Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated (Creatinine clearance should be calculated per institutional standard) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥45 mL/min for subjects with creatinine levels \> 1.5 X institutional ULN
Hepatic\* o Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN; ≤ 3 X ULN for subjects with liver metastases o AST ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
Albumin \>2.5 mg/dL
Coagulation\*
International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT is within therapeutic range of intended use of anticoagulants
Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants \* If laboratory criteria are not met due to what the investigator determines to be a biologic cause (e.g. Gilbert's syndrome causing elevated bilirubin or excessive muscle mass affecting creatinine) or drug-related cause (e.g. elevating in transaminases due to HAART therapy, elevated INR due to anticoagulation) then the lab values will not be used to exclude subject from this trial. This determination will be made by PI.

Exclusion

Vitiligo, alopecia, psoriasis or any chronic skin condition that does not require systemic therapy
Hypothyroidism (e.g. following autoimmune thyroiditis) stable on thyroid replacement
Celiac disease controlled by diet alone

What this trial measures

  • Number of dose limiting toxicities (DLTs)up to 30 days post last administration of study drug dupilumab

    Phase 2: Safety of treatment, defined as the frequency and percentage of DLTs, from start of treatment up to 30 days post the last administration of study drug (dupilumab).