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Durvalumab + Histotripsy for Liver Cancer

(CODAH Trial)

CC
Overseen ByCancer Connect
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Wisconsin, Madison
Must be taking: Durvalumab
Must not be taking: Immunosuppressive drugs
Disqualifiers: Pregnancy, Autoimmune disease, Bleeding disorders, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to evaluate whether adding histotripsy to maintenance durvalumab increases immune response and to assess the safety of this combination for participants with advanced intrahepatic cholangiocarcinoma (iCCA). Histotripsy is a non-invasive, non-thermal treatment that uses focused ultrasound energy to destroy tumor tissue. 12 people will be enrolled in this study.

Who Is on the Research Team?

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John Swietlik, MD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for adults with advanced intrahepatic cholangiocarcinoma (a type of liver cancer). Participants should be well enough to take part and meet specific health requirements. People with certain other medical conditions or who can't safely undergo the treatments will not be eligible.

Inclusion Criteria

I have been diagnosed with intrahepatic cholangiocarcinoma.
My intrahepatic cholangiocarcinoma can be treated with histotripsy.
My single tumor is at least 2.0 cm in its longest dimension.
See 18 more

Exclusion Criteria

Participant has a history of bleeding disorders or is suspected to have a bleeding disorder
I have a bleeding disorder that cannot be corrected.
Participants' tumor(s) is not targetable per discretion of radiologist
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive histotripsy treatment and maintenance durvalumab therapy

4 weeks
3 research specific visits; pre-histotripsy treatment (C1D3), 14-day post histotripsy follow-up with biopsy (C1D22), and 30-day post histotripsy treatment adverse events assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Durvalumab
  • Histotripsy

Trial Overview

The study tests if combining durvalumab (an immunotherapy drug) with histotripsy (a focused ultrasound treatment that destroys tumors without surgery) is safe and boosts immune response, compared to using durvalumab alone. Only 12 participants are involved.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Participants with advanced iCCAExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

HistoSonics, Inc.

Industry Sponsor

Trials
9
Recruited
5,200+

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