PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Background: One way to treat liver cancer is to deliver chemotherapy drugs only to the liver (and not to the whole body). Researchers want to see if adding the drug PDS01ADC can improve the treatment. The drug triggers the immune system to fight cancer.\<TAB\> Objective: To see if treatment with HAIPs to deliver liver-directed FUDR and Dexamethasone chemotherapy in combination with PDS01ADC is effective for certain cancers. Eligibility: People aged 18 and older who have cancer of the bile ducts that is only in the liver, or colorectal cancer that has spread to the liver, or cancer of the adrenal glands that has spread to the liver, who are also receiving or planning to receive standard systemic chemotherapy for their disease. Design: Participants will be screened with: Medical history Physical exam Blood tests Pregnancy test (if needed) Tumor biopsy (if needed) Electrocardiogram Computed tomography (CT) scans Participants will have an abdominal operation. A catheter will be placed into an artery that feeds blood to the liver. The catheter will then be attached to the HAIP. The HAIP will lay under the skin on the left side of the abdomen. All participants will have liver-directed FUDR and Dexamethasone chemotherapy drugs or heparin with saline infused into the HAIP every 2 weeks. PDS01ADC will be injected under the skin every 4 weeks. They will receive this treatment until their cancer gets worse or they have bad side effects. Participants will also receive standard systemic chemotherapy for their disease, assigned based on diagnosis, through an IV by their medical oncologist (at NIH or by a local provider) every 2 weeks. Participants will have 2 study visits at NIH each month. They will have CT scans every 8 weeks. At visits, they will repeat some screening tests. Participants will have a follow-up visit 1 month after treatment ends. Then they will be contacted every 6 months for 5 years.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub starszy
- •Potwierdzony rak jelita grubego z przerzutami do wątroby, rak dróg żółciowych w wątrobie lub rak przytarczy z przerzutami do wątroby
- •Lekarz onkolog zaplanował standardową chemioterapię zgodną z typem raka
- •Ujemny test ciąży (dla osób mogących zajść w ciążę)
- •Zgoda na stosowanie bardzo skutecznej antykoncepcji przez czas badania i 3-6 miesięcy po jego zakończeniu
- •Anatomia tętnic widoczna w tomografii komputerowej pozwala na wszczepieniepompy
- •Kobiety karmiące piersią muszą przerwać karmienie
- •Podpisana świadoma zgoda na udział w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 120 Years
- Last updated (source)
- July 10, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
National Institutes of Health Clinical Center
Bethesda, United States
Trial contact
Kathleen M Smith, R.N.
Jonathan M Hernandez, M.D.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/11/2026.
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