New device combo for liver chemotherapy shows promise in small trial

NCT ID NCT03693807

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a Medtronic pump and Codman catheter can safely deliver chemotherapy directly to the liver in 35 people with colorectal cancer or bile duct cancer that spread to the liver. The main goal was to check safety, including liver side effects and need for stent replacements. This approach aims to control the disease, not cure it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

35 people

The number who actually took part.

Started

Oct 2018

Finished

Jun 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinicalyl or radiographically confirmed extrahepatic disease (or) Histologically confirmed cholangiocarcinoma (Clinical or radiographic evidence of metastatic disease that has been resected is allowed, provided there is no recurrence in that area prior to protocol consent) * Confirmation of diagnosis must be performed at MSKCC * Patient may have completely resected hepatic metastases without current evidence of other metastatic disease * Lab values ≤14 days prior to registration: * WBC ≥2.5 K/uL * Platelets ≥100,000/uL * Creatinine \<1.7mg/dL * HGB ≥ 8.5 gm/dL * Total Bilirubin ≤1.5 mg/dl * Prior chemotherapy is acceptable if last dose given ≥3 weeks prior to registration to this study. \[Note: no chemotherapy to be given after resection of liver lesions prior to treatment on this study\] * Any investigation agent is acceptable if administered ≥3 months before planned first dose on this protocol * KPS ≥60% * Patients ≥18 years of age Exclusion Criteria: * Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if competed at least 4 weeks prior to the planned first dose of treatment on protocol) * Active infection, ascites, hepatic encephalopathy * Female patients who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test ≤72 hours before treatment start) * If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment * Patients with current evidence of hepatitis A, B, C (i.e., active hepatitis) * Patients with history or known presence of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke will also be excluded * Serious or non-healing active wound, ulcer, or bone fracture * History of other malignancy, except: 1. Malignancy treated with curative intent and with no known active disease present for ≥3 years prior to registration and felt to be at low risk for recurrence by the treating physician 2. Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease 3. Adequately treated cervical carcinoma in situ without evidence of disease There is no exclusion of patients based on sex, ethnicity or race. For these reasons, the study results are expected to be generalizable to the Medicare beneficiary population.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

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