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Atezolizumab for Biliary Tract Cancer
Study Summary
This trial will test if adding atezolizumab and bevacizumab to cisplatin and gemcitabine will work better than just adding atezolizumab to cisplatin and gemcitabine to treat advanced biliary tract cancer in people who haven't had prior systemic therapy.
- Biliary Tract Cancer
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT02008227Trial Design
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Who is running the clinical trial?
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- Your disease has come back within 6 months after surgery or after you finished additional treatment.You have received previous treatments like radioembolization in the area being studied.You have cancer that has spread to your brain and it is causing symptoms or getting worse, and you are not receiving any treatment for it.You have a history of very high blood pressure that caused severe problems in your brain.You have a serious wound, ulcer, or broken bone that is not healing or being treated.You are taking a non-steroidal anti-inflammatory drug (NSAID) every day.You have existing kidney problems, low blood cell count, or hearing problems.You have not received any previous treatment for advanced biliary tract cancer.Your bile ducts are draining properly and you don't have any signs of ongoing infection.You have a history of certain lung diseases or evidence of ongoing lung inflammation based on a chest scan.You have had cancer other than bile duct cancer within the past 5 years, unless it was a type of cancer that is not likely to spread or cause serious harm.You have a serious condition related to your blood vessels.You are expected to live for more than 3 months.You have experienced a recent bleeding event in your esophagus or stomach veins that has not been fully treated within the last 6 months.You currently have or have had a disease that affects your immune system.Your high blood pressure is not well controlled.
- Group 1: Arm A: Atezo+Bev+CisGem, followed by Atezo+Bev
- Group 2: Arm B: Atezo+PBO+CisGem, followed by Atezo+PBO
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What potential risks does Atezolizumab pose to people?
"Atezolizumab is deemed to be moderately safe, as it has been graded a 2 out of 3. This rating acknowledges the existing safety data from this phase two trial without any efficacy evidence yet available."
Can you elucidate any prior research projects involving Atezolizumab?
"Currently, 1527 studies are conducting analysis on Atezolizumab with 452 of them at the final phase 3. While most trials take place in Shanghai, there is a total number of 77605 locations running investigative research on this drug."
How many participants are being monitored in this research endeavor?
"At this moment, the clinical trial is not taking on new patients. Initially posted in February 2021 and last updated in September 2022, it appears to be closed for enrollment. Should you seek other trials related to biliary tract cancer or Atezolizumab, there are presently 104 and 1527 studies actively looking for participants respectively."
How many medical centers have implemented this clinical trial?
"11 medical centres are currently conducting this trial, including University of Virginia in Charlottesville, Uni of Southern California; Norris Comprehensive Cancer Ctr in Los Angeles and Centre Universitaire de sante de l'Estrie (CHUS) in Sherbrooke. Additionally, several other locations have been approved to participate as well."
What medical conditions is Atezolizumab regularly used to address?
"Atezolizumab is often used to abate recurrent platinum-sensitive epithelial ovarian cancer, but has also been found to be beneficial for metastatic ureter urothelial carcinoma, malignant neoplasms, and chronic cervical cancer."
Are there any vacancies available in this study for participants?
"This experiment, which was initially posted on February 23rd 2021, is not currently accepting patients. The study's most recent update occured on September 29th 2022 and as of now there are no more recruitment needs. However, 1631 other studies remain in search for test subjects."
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