Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma.
Alex B Blair, Wilson M Alobuia, Manisha Palta...
https://pubmed.ncbi.nlm.nih.gov/40812353Actively Recruiting
Phase 2
Age: 18Years - 120Years
All Genders
ID05286814
Phase II Study of PDS01ADC with Hepatic Artery Infusion Pump and Systemic Chemotherapy for Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-04
70
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether adding the drug PDS01ADC to liver-directed chemotherapy using a hepatic artery infusion pump (HAIP) combined with systemic chemotherapy can improve treatment for people with certain liver-related cancers. These include bile duct cancer limited to the liver, colorectal cancer that has spread to the liver, and adrenal gland cancer that has spread to the liver. The study is a Phase II, open-label trial focused on these cancers, aiming to evaluate the effectiveness of this combined approach. The treatment involves surgery to place a catheter and the HAIP under the skin on the left side of the abdomen. Participants will receive liver-directed chemotherapy with Floxuridine (FUDR) and Dexamethasone infused via the HAIP every two weeks, along with PDS01ADC injections under the skin every four weeks. They will also receive standard systemic chemotherapy through an IV every two weeks based on their cancer type. Treatment continues until the cancer worsens or side effects become unacceptable. During the study, participants will have two visits per month at the research center, including CT scans every eight weeks and repeat tests such as blood work and physical exams. After treatment ends, there will be a follow-up visit one month later, then contact every six months for up to five years. Researchers will measure tumor response rates, survival, disease progression, and safety throughout the study.
CONDITIONS
Brief Title
PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
Who Can Participate
Age: 18Years - 120Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with metastatic colorectal cancer, intrahepatic cholangiocarcinoma, or adrenocortical carcinoma with liver-dominant disease
- Planning to receive or currently receiving standard chemotherapy appropriate for cancer type (FOLFOX, FOLFIRI, GemOx)
- Negative pregnancy test if of childbearing potential
- Agree to use highly effective contraception during and after the study
- Agree to discontinue nursing if breastfeeding
- Suitable arterial anatomy for hepatic artery infusion pump placement
- HIV-positive with undetectable viral load allowed
- Liver metastases not removable to no evidence of disease in one surgery
- ECOG performance status 0 or 1
- Adequate organ and marrow function as specified in protocol
- Must have received first-line systemic chemotherapy (specific to cancer type)
- Participants must sign informed consent
- Agree to tissue collection protocol
You will not qualify if you...
- Receiving other investigational treatments
- Previous treatment with recombinant IL-12
- Active autoimmune diseases except specified controlled conditions
- History of organ transplant requiring immunosuppression
- Active inflammatory bowel disease
- Known allergies to study drugs or related compounds
- Recent significant cardiovascular events or serious heart conditions
- Conditions causing significant non-tumor tissue necrosis
- Recent esophageal or gastroduodenal ulcers
- Active ischemic bowel disease
- Psychiatric or social conditions limiting study compliance
- Other active cancers within 5 years except certain skin or thyroid cancers
- Prior radiation to the liver
- Active hepatitis B or C infection
- Significant infections including tuberculosis
- Any condition increasing risk or confounding study data
- For colorectal cancer: evidence of disease outside liver and colon/rectum beyond allowed exceptions
- Prior treatment with Floxuridine
- For intrahepatic cholangiocarcinoma: distant metastases, sclerosing cholangitis, portal hypertension
- For adrenocortical carcinoma: unresectable abdominal disease outside liver, portal hypertension, sclerosing cholangitis, recent progressive lung metastases, untreated mismatch repair mutation requiring checkpoint inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive PDS01ADC by subcutaneous injection on Day 15 of every cycle combined with hepatic artery infusion pump (HAIP) delivering Floxuridine and Dexamethasone on Days 1-14 of each cycle, alongside systemic chemotherapy such as FOLFOX, FOLFIRI, or GemOx. The pump is flushed with heparin/saline on Days 15-28 of each cycle. Dose adjustments may occur based on liver enzyme levels.
1 visit every 2 weeks for treatment administration and pump management
Follow-up
Duration - Up to 5 years after treatment completion
Participants are monitored after treatment ends to assess overall survival, progression-free survival, and safety of the treatment combination.
Follow-up visits approximately every 8 weeks during the first year, then less frequently as determined by the study team
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
K
Kathleen M Smith, R.N.
J
Jonathan M Hernandez, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Hepatic artery infusion pump (HAIP) therapy in combination with targeted delivery of IL-12 for patients with metastatic colorectal cancer or intrahepatic cholangiocarcinoma: a phase II trial protocol.
Jack H Victory, Emily C Smith, Carrie E Ryan...
https://pubmed.ncbi.nlm.nih.gov/38989414