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Monoclonal Antibodies

Treatment (Sacituzumab govitecan) for Intrahepatic Cholangiocarcinoma

Phase 2

Recruiting

Led By Anup K Kasi Loknath Kumar

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

Locally advanced, recurrent or metastatic cholangiocarcinoma) after progressing or intolerant to at least one line of systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment, up to 2 years

Awards & highlights

Study Summary

This trial is testing a treatment called sacituzumab govitecan for patients with a type of cancer called cholangiocarcinoma. This cancer can be locally advanced, recurrent, or

Who is the study for?

This trial is for patients with advanced forms of bile duct cancer, including those whose cancer has spread locally, returned after treatment, or metastasized. Participants must have measurable disease and be able to undergo procedures like biopsies and scans.Check my eligibility

What is being tested?

The trial is testing Sacituzumab Govitecan's effectiveness on cholangiocarcinoma. It involves a monoclonal antibody targeting TROP2 receptors on tumor cells to deliver the toxic agent SN-38 directly to them.See study design

What are the potential side effects?

Sacituzumab Govitecan may cause side effects such as nausea, diarrhea, hair loss, fatigue, decreased blood cell counts leading to higher infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of the day.

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My bile duct cancer has worsened or didn't respond to at least one treatment.

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My kidneys are functioning well enough for treatment.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment, up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate

Secondary outcome measures

Anti-tumor activity: Disease control rate

Anti-tumor activity: Duration of response

Incidence of adverse events

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Sacituzumab govitecan)Experimental Treatment6 Interventions

Patients receive sacituzumab govitecan IV over 1-3 hours on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, PET/CT or MRI scans, and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1700

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

463 Previous Clinical Trials

169,248 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,670 Previous Clinical Trials

40,926,714 Total Patients Enrolled

4 Trials studying Intrahepatic Cholangiocarcinoma

1,157 Patients Enrolled for Intrahepatic Cholangiocarcinoma

Anup K Kasi Loknath KumarPrincipal InvestigatorUniversity of Kansas

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted its official approval for the use of Sacituzumab govitecan as a treatment?

"Based on our assessment as the Power team, we rate the safety of Treatment (Sacituzumab govitecan) with a score of 2. This is because it is currently in Phase 2 trial where there is existing data to support its safety but no evidence yet regarding its efficacy."

Answered by AI

Is the enrollment process for this medical study currently open and accepting participants?

"Indeed, as per the information available on clinicaltrials.gov, this particular clinical trial is not currently seeking participants. The initial posting of the study took place on December 31st, 2023, and it was most recently updated on December 20th, 2023. However, please note that there are presently a total of 1186 other studies actively accepting patients for participation at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sacituzumab Govitecan for the Treatment for Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma

Anup Kasi 2024. "Sacituzumab Govitecan for the Treatment for Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06178588.

All > Intrahepatic Cholangiocarcinoma > Cholangiocarcinoma