Hepatic Artery Infusion Chemotherapy for Liver Cancer

Overseen By Yvonne Taul, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Michael J Cavnar, MD

Must not be taking: Bevacizumab

Disqualifiers: Distant metastases, MSI/MMR-D, 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: Unknown

Duration: 3-4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of delivering chemotherapy directly to the liver using a small pump. It aims to assist individuals with liver cancer that has spread from colorectal cancer or with intrahepatic cholangiocarcinoma. The researchers aim to determine if this delivery method is safe and if patients can have their pump refilled at home or a local clinic instead of in a hospital. Suitable candidates for this trial include those with liver cancer who have previously undergone chemotherapy and can participate in telehealth visits for some aspects of their care. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are taking Bevacizumab (Avastin®), you must stop it at least 6 weeks before starting the trial.

What prior data suggests that hepatic artery infusion chemotherapy is safe for liver cancer patients?

Research has shown that hepatic artery infusion chemotherapy (HAI) is generally easy for patients to handle. Early studies suggest that most people's quality of life returns to normal about three months after starting treatment, indicating that the treatment usually doesn't cause long-lasting negative effects for most people.

Another study examined the safety and practicality of HAI, finding that the treatment can be administered safely and works well for many patients. Safety information from past patients indicates that HAI is a promising option for treating liver cancer and related conditions, with manageable side effects.

While these findings are encouraging, it is important to note that this trial is in Phase 2. In this phase, researchers continue to learn about the treatment’s safety and its effects on different people. Overall, current evidence suggests that HAI is a safe option with potential benefits, but individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about hepatic artery infusion (HAI) chemotherapy for liver cancer because it offers a targeted delivery method that directly administers chemotherapy to the liver, potentially increasing the concentration of the drug at the tumor site while reducing systemic side effects. Unlike traditional systemic chemotherapy, which circulates throughout the entire body, HAI focuses on the liver, which may make it more effective for liver tumors. Additionally, the trial investigates innovative care delivery models, including home pump fills and telehealth oversight, which could improve patient convenience and accessibility compared to frequent visits to oncology centers.

What evidence suggests that hepatic artery infusion chemotherapy is effective for liver cancer?

Research has shown that hepatic artery infusion chemotherapy (HAIC) can be effective for liver cancer. Studies have found that HAIC helps patients live longer and delays disease progression more effectively than treatments like transarterial chemoembolization (TACE) and standard chemotherapy. For example, one study found that HAIC increased overall survival by about 49% and delayed disease progression by about 45% compared to TACE. Another study showed that HAIC had tumor response rates between 20% and 71%, with patients living between 7.3 to 15.9 months on average. Although some risks exist, such as scarring of the bile duct, the potential for better outcomes makes HAIC a promising option for treating liver cancer. Participants in this trial will receive HAIC either through the Tertiary Oncology Cohort, following usual institutional protocols, or through the Community Oncology Cohort, with home infusion and telehealth oversight. ^{3 6 7 8 9}

Who Is on the Research Team?

Michael Cavnar, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals with colorectal liver metastases, either resectable or unresectable, and those with unresectable intrahepatic cholangiocarcinoma. Participants will undergo surgery to install a hepatic artery infusion pump and can choose to receive follow-up care locally or at the hospital.

Inclusion Criteria

Lab values within specified ranges

My colorectal cancer has spread to my liver and cannot be surgically removed.

I have been diagnosed with a type of liver cancer that cannot be removed by surgery.

Exclusion Criteria

Clinical evidence of portal hypertension

Pregnant, lactating, or planning pregnancy within specified timeframe

Serious medical problems precluding treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants will have surgery to install a pump which is a standard surgical procedure

1 week

Treatment

Participants receive hepatic artery infusion chemotherapy for 3-4 months, with options for treatment at a hospital facility or with a community oncologist

3-4 months

Visits every two weeks for Tertiary Oncology Cohort; home infusions and telehealth for Community Oncology Cohort

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the continued use of the HAI pump

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Hepatic Artery Infusion Chemotherapy

Trial Overview The study tests the safety of hepatic artery infusion chemotherapy via an installed pump, comparing home/local clinic refills versus hospital-based treatment. It aims to determine if this method is feasible for routine cancer care outside large medical centers.

How Is the Trial Designed?

Group I: Community Oncology Cohort (CO) Experimental Treatment 4 Interventions

HAI pump fills in home by a home infusion company; systemic therapy treatments at the community oncology office; oversight via telehealth visits

Group II: Tertiary Oncology Cohort (TO) Active Control 4 Interventions

receive care as per usual institutional protocol, visits every two weeks and standard manual HAI dose calculation.

Who Is Running the Clinical Trial?

Michael J Cavnar, MD

Lead Sponsor

Trials

1

Recruited

20+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39565488/

Perioperative and Oncologic Outcomes of Hepatic Arterial ... Postoperative HAI-specific complications occurred in 23% of patients, including biliary sclerosis in 6%, and the 90-day mortality rate was 3%.

2. hbsn.amegroups.org hbsn.amegroups.org/article/view/141256/html

Efficacy of hepatic arterial infusion chemotherapy in advanced ... Results: HAIC significantly improved OS [hazard ratio (HR) =0.51] and PFS (HR =0.55) compared to TACE in advanced HCC. Subgroup analyses ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772947825000210

Efficacy analysis of hepatic arterial infusion chemotherapy ... Following evaluation, 10 patients were successfully converted, with 6 ultimately undergoing curative liver cancer resection; of these 6 patients ...

4. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1640970/full

Hepatic arterial infusion chemotherapy versus systemic ... Results: HAIC significantly improved OS (HR = 0.51, p < 0.001) and PFS (HR = 0.58, p < 0.001) compared to systemic chemotherapy. Subgroup ...

5. mdpi.com mdpi.com/1718-7729/32/6/313

Hepatic Artery Infusion Chemotherapy for Hepatocellular ... As a monotherapy, the FP-HAIC regimen demonstrated 20–71% tumor response rates and 7.3- to 15.9-month median OS in advanced HCC with portal vein invasion in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10189040/

Efficacy and safety of hepatic artery infusion chemotherapy ... Results · OS and PFS. There were 97 deaths during the follow-up period, including 48 deaths (64.00%) in the HAIC+T+P group and 49 deaths (66.21%) ...

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 ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.4_suppl.120

Perioperative and oncologic outcomes of hepatic artery ... We now report safety, feasibility, efficacy and oncologic outcomes for an expanded cohort of 62 patients in an established HAI program.

9. mdpi.com mdpi.com/1718-7729/32/2/87

The Efficacy and Safety of Hepatic Artery Infusion ... This study focuses on evaluating the effectiveness and safety of hepatic arterial infusion chemotherapy (HAIC) in combination with lenvatinib plus programmed ...