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Immune Therapy + Chemotherapy for Bile Duct Cancer (ESR-22-21719 Trial)

Phase 2

Recruiting

Led By Aiwu R He, MD

Research Sponsored by Georgetown University

Eligibility Criteria Checklist

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

Must have

Patients with histologically proven intrahepatic cholangiocarcinoma, untreated with systemic therapy

Patients with serum creatinine < 1.5 times institutional upper limit of normal (ULN), measured creatinine clearance > 40 mL/min or Calculated creatinine clearance > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24 hour urine collection for determination of creatinine clearance

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

ESR-22-21719 Trial Summary

This trial tests a new combination of drugs to see if it can make tumors resectable, and what side effects it may have, for people with cholangiocarcinoma.

Who is the study for?

This trial is for adults with intrahepatic cholangiocarcinoma (a type of bile duct cancer) that's either borderline resectable or has a high risk of coming back after surgery. They should not have had previous systemic therapy, must be in good health with a life expectancy over 6 months, and have no other active cancers or serious medical conditions.Check my eligibility

What is being tested?

The trial tests if combining tremelimumab and durvalumab with gemcitabine and cisplatin can make tumors operable when they weren't before. Participants will get these drugs for up to 8 cycles before potential surgery, followed by additional treatment if needed.See study design

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, fatigue, nausea, liver enzyme changes, low blood counts increasing infection risk, kidney function changes, and allergic reactions to the drugs used.

ESR-22-21719 Trial Eligibility Criteria

Inclusion Criteria

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

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I have a type of liver cancer called intrahepatic cholangiocarcinoma and haven't received any systemic therapy for it.

Select...

My kidney function is within the normal range according to tests.

Select...

My bilirubin levels are within the normal range, or slightly above.

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I weigh at least 30 kg.

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I am fully active or have some restrictions but can still care for myself.

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My cancer has not spread beyond my liver, except possibly to nearby lymph nodes.

ESR-22-21719 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of related treatment emergent adverse events

Rate of Conversion from unresectable to resectable

Secondary outcome measures

Event Free Survival (EFS)

Objective Response Rate (ORR)

Overall survival (OS)

+5 more

ESR-22-21719 Trial Design

1Treatment groups

Experimental Treatment

Group I: Durvalumab and Tremelimumab plus gemcitabine/cisplatinExperimental Treatment5 Interventions

Durvalumab and tremelimumab plus gemcitabine/cisplatin combination therapy. If the tumor is evaluated to be resectable after Cycle 4 (C4), then the patient may proceed with surgical tumor resection. If the tumor is deemed unresectable after C4, then the patient will proceed with Cycle 5-8 followed by reevaluation for surgical resection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Surgical Resection

2018

Completed Phase 2

~420

Cisplatin

2013

Completed Phase 3

~1940

Tremelimumab

2017

Completed Phase 2

~3380

Gemcitabine

2017

Completed Phase 3

~2070

Durvalumab

2017

Completed Phase 2

~3870

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor

343 Previous Clinical Trials

136,474 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,271 Previous Clinical Trials

288,612,675 Total Patients Enrolled

Aiwu R He, MDPrincipal InvestigatorGeorgetown University

Frequently Asked Questions

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

Is registration still available for this experiment?

"Unfortunately, this clinical trial is no longer open for recruitment. It was originally posted on November 1st 2023 and last updated a few months ago on September 15th 2023. However, there are currently 289 other active trials recruiting patients as of now."

Answered by AI

What safety risks are associated with Durvalumab and Tremelimumab plus gemcitabine/cisplatin treatment?

"Our evaluation at Power deems the safety of Durvalumab and Tremelimumab plus gemcitabine/cisplatin to be a 2 as this trial is currently in Phase 2, which means limited information exists on its efficacy but some data supports its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma

2024. "Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06017297.

All > Intrahepatic Cholangiocarcinoma > Bile Duct Cancer