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NCT05286814 · ClinicalTrials.gov registry record · Phase 2
PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
A Phase 2 study of Colorectal Cancer and Cholangiocarcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT05286814: Recruiting Phase 2 study of Colorectal Cancer and Cholangiocarcinoma, sponsored by National Cancer Institute (NCI).
NCT05286814 is a Phase 2 study of Colorectal Cancer and Cholangiocarcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 70 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05286814, a Phase 2 study of Colorectal Cancer and Cholangiocarcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Simon optimal two-stage Phase II trial design will be used to determine overall response using RECIST criteria. The clinical response rate (CR+PR) will be determined and reported along with a 95% confidence interval, separately by cohort.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG PDS01ADC
- DEVICE Intera 3000 Hepatic Artery Infusion Pump (HAIP)
- DRUG Floxuridine
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2022-10-24 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What NCT05286814 shows while recruiting
NCT05286814 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (95% lower).
The record links to 10 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 4 interventions - of which Dexamethasone is the first listed.
NCT05286814 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05286814 about?
NCT05286814 is a clinical study titled "PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma". 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 ...
What is the current status of trial NCT05286814?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2022-10-24. Estimated completion is 2028-12-31.
What conditions does trial NCT05286814 study?
This clinical trial studies the following conditions: Colorectal Cancer, Cholangiocarcinoma, Colorectal Neoplasms, Bile Duct Cancer, Adrenal Cortical Carcinoma.
What interventions are being tested in trial NCT05286814?
The interventions under investigation include: Dexamethasone (DRUG), PDS01ADC (DRUG), Intera 3000 Hepatic Artery Infusion Pump (HAIP) (DEVICE), Floxuridine (DRUG).
Who is sponsoring clinical trial NCT05286814?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05286814 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05286814's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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