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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

Must not have

Patients with legal incapacity

Patients with hilar or distal cholangiocarcinoma or those with hepatocholangiocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am legally unable to make my own medical decisions.

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I have cancer in my bile ducts or a mix of liver and bile duct cancer.

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My cancer has spread beyond the liver to other areas.

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I have had cancer spread to the lining of my brain and spinal cord.

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I have had or currently have lung inflammation treated with steroids.

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I do not have any serious, uncontrolled conditions that would stop me from receiving therapy.

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I cannot have surgery for my bile duct cancer due to other health issues like severe liver disease.

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My liver tumor is eligible for surgery or transplantation.

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I have severe diarrhea that is hard to control.

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I haven't had extensive radiation therapy affecting over 30% of my bone marrow or wide field radiation in the last 4 weeks.

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I have hepatitis B or C, and if I have HBV, I am receiving treatment for it.

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My thyroid condition is stable with medication.

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I have a skin condition that doesn't need treatment with pills or injections.

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I am allergic or cannot take durvalumab, tremelimumab, gemcitabine, cisplatin, or capecitabine due to severe reactions.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of related treatment emergent adverse events

Rate of Conversion from unresectable to resectable

Secondary study objectives

Objective Response Rate (ORR)

Overall survival (OS)

Patient Reported outcomes (PRO) decline

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Gemcitabine

2017

Completed Phase 3

~1920

Durvalumab

2017

Completed Phase 2

~3750