20 Participants NeededMy employer runs this trial

Gemcitabine + Cisplatin + Nab-paclitaxel + Cemiplimab for Biliary Tract Cancer

(GAP Cemi Trial)

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Overseen ByResearch Nurse Navigator
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

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is being conducted to find out if treatment with gemcitabine, cisplatin, nab-paclitaxel, and cemiplimab can shrink previously inoperable tumors enough for surgery.

Who Is on the Research Team?

LW

Linda Wu, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with biliary tract adenocarcinoma.
My liver has one shrunken lobe and the tumor has spread to the other side's vessels or bile duct.
My tumor affects both lobes of my liver or involves blood vessels.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cemiplimab in addition to chemotherapy drugs (gemcitabine, cisplatin, and nab-paclitaxel) to shrink tumors for potential surgical resection

6 months

Follow-up

Participants are monitored for safety, effectiveness, and surgical resection outcomes after treatment

up to 5 years

Long-term follow-up

Participants are monitored for recurrence-free survival and overall survival

up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Cemiplimab

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: CemiplimabExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School