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Rilvegostomig + Chemotherapy for Biliary Tract Cancer (ARTEMIDE-Bil01 Trial)

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic) after macroscopically complete resection (R0 or R1)

Eastern Cooperative Oncology Group performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

ARTEMIDE-Bil01 Trial Summary

This trial will compare a new cancer drug versus a placebo to see if it helps treat bile duct cancer after surgery.

Who is the study for?

This trial is for individuals who've had surgery to remove biliary tract cancer and are now disease-free. They should have a performance status indicating they can carry out daily activities with ease or minor limitations, and must not have used immunosuppressive drugs recently, nor have autoimmune disorders, severe diseases, recent thromboembolic events, or active hepatitis infections.Check my eligibility

What is being tested?

The study compares the effectiveness of Rilvegostomig plus chemotherapy against a placebo combined with chemotherapy in patients who've undergone surgery for biliary tract cancer. The goal is to see if Rilvegostomig can prevent the cancer from coming back.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system due to Rilvegostomig, as well as typical chemotherapy-related issues like nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems.

ARTEMIDE-Bil01 Trial Eligibility Criteria

Inclusion Criteria

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

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My bile duct cancer was confirmed by a lab test and has been fully removed.

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I am fully active or can carry out light work.

ARTEMIDE-Bil01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 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

Recurrence free survival (RFS) for Arm A vs. Arm B

Secondary outcome measures

Overall Survival (OS) for Arm A vs. Arm B

Other outcome measures

Patient-reported tolerability Arm A vs. Arm B.

Progression Free Survival (PFS) following recurrence Arm A vs. Arm B.

ARTEMIDE-Bil01 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm AExperimental Treatment4 Interventions

Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)

Group II: Arm BPlacebo Group4 Interventions

Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

2013

Completed Phase 3

~3420

Gemcitabine/Cisplatin

2007

Completed Phase 3

~750

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,272 Previous Clinical Trials

288,611,925 Total Patients Enrolled

Frequently Asked Questions

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

Has Arm A received official clearance by the FDA?

"There is a wealth of clinical data that suggest the safety of Arm A, so it received an overall score of 3."

Answered by AI

How many health care institutions are currently participating in this research endeavor?

"Currently, 57 medical sites are recruiting potential patients for this trial. These locations span from Murdoch to Reservoir and Westmead as well as other locales. To minimize travel needs it is recommended that those interested in enrolling pick the closest clinic available."

Answered by AI

Are any participants currently being enrolled in this experiment?

"This experiment, which was initially posted on December 8th 2023 and last updated a few weeks ago, is no longer recruiting patients. Fortunately, there are 109 other trials in the same field that remain open to participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

2023. "Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06109779.

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