HAIP Chemotherapy for Metastatic Colorectal Cancer

Overseen By Jonathan M Hernandez, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Check-point inhibitors

Disqualifiers: Active malignancies, Uncontrolled illness, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 28-day cycles

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat colorectal cancer that has spread to the liver. The focus is on using a special pump to deliver chemotherapy directly to the liver, known as HAIP installation, to improve treatment outcomes. Participants should have colorectal cancer with liver metastases that have not responded to standard chemotherapy. The study involves hospital visits for treatment and regular check-ups to monitor progress. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are receiving other investigational agents, and you should discuss your current medications with the study team to ensure they don't interfere with the trial.

What prior data suggests that this hepatic artery infusion pump is safe for treating colorectal metastases to the liver?

Research has shown that using a hepatic artery infusion pump (HAIP) for treatment is generally well-tolerated. In past studies, 96.1% of patients received HAIP chemotherapy without issues after setup, demonstrating the procedure's practicality. Patients experienced lasting benefits with few side effects, indicating HAIP's effectiveness and safety. Moreover, any effect on quality of life appears minimal, as most patients return to their normal state within three months of starting treatment. These findings suggest that HAIP chemotherapy is a promising and safe option for treating liver metastases in colorectal cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about HAIP chemotherapy for metastatic colorectal cancer because it offers a unique delivery method. Unlike traditional chemotherapy, which travels through the bloodstream, HAIP (Hepatic Arterial Infusion Pump) delivers chemotherapy directly into the liver, where liver metastases from colorectal cancer often occur. This targeted approach allows for higher concentrations of the cancer-killing drug floxuridine to reach the tumors, potentially increasing effectiveness while reducing systemic side effects. Additionally, the combination with dexamethasone might help manage inflammation and enhance treatment tolerance. This innovative method could provide a more effective and tolerable option for patients compared to standard systemic chemotherapy.

What evidence suggests that the hepatic artery infusion pump is effective for treating colorectal metastases to the liver?

Research has shown that using a hepatic artery infusion pump (HAIP) for chemotherapy may effectively treat colorectal cancer that has spread to the liver. In one study, 61% of patients were still alive 10 years after undergoing surgery to remove cancer from the liver and receiving HAIP treatment. This method often provides long-lasting effects and is generally manageable for patients. Additionally, HAIP is associated with a better quality of life compared to traditional chemotherapy and appears to reduce the risk of cancer recurrence in the liver. Participants in this trial will receive HAIP chemotherapy combined with systemic chemotherapy to further evaluate its effectiveness. ^{2 4 5 6 7}

Who Is on the Research Team?

Jonathan M Hernandez, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Adults over 18 with colorectal cancer that has spread to the liver, who have tried or can't tolerate certain chemotherapy regimens. They must be in good physical condition (ECOG ≤1), have proper organ and marrow function, and agree to use contraception. Excluded are those with high-risk genetic features needing other treatments, serious illnesses, active infections like Hepatitis B/C, pregnant/nursing women, other cancers within five years (except some skin/thyroid cancers), or those eligible for complete surgical removal of liver metastases.

Inclusion Criteria

Ability of subject to understand and the willingness to sign a written informed consent document.

HIV-positive patients may be considered for this study only after consultation with an HIV trained physician.

Your arteries, as seen on a special type of scan called CT angiogram, should be suitable for placing a device called HAIP (hepatic artery infusion pump).

Exclusion Criteria

My liver cancer can be surgically removed until there's no visible disease.

You have had allergic reactions to medicines that are similar to FUDR or heparin.

My lung cancer has less than 5 large tumors, stable for 4 months, and can be surgically removed if needed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive hepatic artery infusion pump chemotherapy with floxuridine and dexamethasone in combination with systemic chemotherapy in 28-day cycles

28-day cycles

Every Day 1: physical exam, symptom review, blood tests; Every 2 weeks: clinic visit for chemotherapy; Every 12 weeks: scan

Follow-up

Participants are monitored for safety and effectiveness after treatment, including calls every 6 months

6 months

Calls every 6 months

Extension

Participants may have the pump removed and repeat Day 1 tests after finishing the drug

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Floxuridine
• HAIP installation

Trial Overview The trial is testing a hepatic artery infusion pump delivering Floxuridine and Dexamethasone directly into the liver combined with systemic chemotherapy drugs like cetuximab and irinotecan. Participants will undergo cycles of treatment including regular exams, blood tests every two weeks for chemo via catheter/port, scans every three months, and possible tissue sampling.

How Is the Trial Designed?

Group I: 1/ Arm 1 Experimental Treatment 9 Interventions

HAIP chemotherapy + Systemic chemotherapy

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 515 rectal cancer patients, those who received perioperative dexamethasone had significantly lower three-year disease-free survival (62.3% vs 71.8%) and overall survival rates (74.1% vs 82.9%) compared to those who did not receive the drug.

The use of dexamethasone was independently associated with worse disease-free survival outcomes, suggesting that avoiding low-dose perioperative dexamethasone may improve survival for patients undergoing curative surgery for rectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avoiding perioperative dexamethasone may improve the outcome of patients with rectal cancer. Yu, HC., Luo, YX., Peng, H., et al.[2021]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.126

Retrospective analysis of HAIP therapy in metastatic ... Conclusions: HAIP treatment is associated with durable responses and few complications, making it well-tolerated by patients. For individuals ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6863781/

Adjuvant Hepatic Arterial Infusion Pump Chemotherapy ... The 10-year overall survival with adjuvant hepatic arterial infusion pump (HAIP) chemotherapy after resection of colorectal liver metastases (CRLMs) was 61% in ...

3. cancerblog.mayoclinic.org cancerblog.mayoclinic.org/2025/03/06/hepatic-artery-infusion-pump-therapy-for-colorectal-liver-metastases/

Hepatic artery infusion pump therapy for colorectal liver ... One of the most significant advantages of HAIP is its improvement in quality of life for patients compared to traditional chemotherapy. While ...

4. asco.org asco.org/abstracts-presentations/ABSTRACT472098

Retrospective analysis of HAIP therapy in metastatic ... HAIP treatment is associated with durable responses and few complications, making it well-tolerated by patients. For individuals with colorectal cancer and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1365182X19332125

The impact of hepatic arterial infusion pump chemotherapy ... Conclusion. Adjuvant HAIP chemotherapy is associated with lower intrahepatic recurrence rates and better DFS and OS after resection of CRLM.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8749357/

Safety and Feasibility of Initiating a Hepatic Artery Infusion ... Furthermore, we demonstrated feasibility since 96.1% of patients received HAIP chemotherapy within 20 days after HAIP insertion and a median number of 5 cycles ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2950247025000386

Prospective evaluation of the quality of life and safety in ... Preliminary data suggests baseline QOL mostly returns within 3 months of HAI placement, and initiation of HAI treatment does not appear to significantly impact ...