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Regorafenib + Durvalumab for Biliary Tract Cancer
Study Summary
This trial will test how well combining Durvalumab and Regorafenib works for participants with biliary track cancer who have had one prior treatment.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I haven't had any major abdominal issues like a fistula or obstruction in the last 8 weeks.I do not have any serious ongoing illnesses like heart failure or lung disease.My condition worsened after at least one treatment.I have been treated with immune checkpoint inhibitors before.My organ functions are within normal ranges according to recent tests.I have an active autoimmune disease and have been treated for it in the last 2 years.I have been treated with regorafenib before.I have HIV, and/or active hepatitis B or C but am receiving treatment.I have severe diarrhea due to a condition like Crohn's disease.I received my last cancer treatment less than 3 weeks ago.I have not had significant bleeding episodes in the last 8 weeks.I don't have lasting side effects from cancer treatment, except for mild neuropathy, hair loss, or skin changes.I have had an organ transplant.I use herbal remedies.I haven't had any other cancer besides my current one in the last 3 years.I do not have a serious ongoing infection.My protein levels in urine are not extremely high.I do not have an active tuberculosis infection.I will stay on antiviral therapy during and 6 months after the study if needed.I have hepatitis C antibodies but no active virus according to PCR tests.I weigh more than 66 lbs.I agree not to donate sperm during and for 6 months after the study.I have fluid buildup that can't be managed with treatment.I have hepatitis B and am on antiviral therapy to control it.I have at least one tumor that can be measured and tracked over time.I am on blood thinners and have stable blood clotting measures.I am fully active or can carry out light work.My blood pressure is high despite taking medication.I or my legal representative can understand the study and agree to sign the consent.I can swallow pills and take my own medication.I haven't had a live vaccine in the last 30 days.I have untreated brain metastases or cancer in the lining of my brain, stable for over 4 weeks.My bile duct or gallbladder cancer can't be surgically removed and has worsened after one treatment.I have recovered from major side effects of my previous treatments.I am not on strong immune system suppressing drugs, except for minor exceptions like inhalers.I have been diagnosed with ampullary carcinoma.I haven't had a stroke, heart attack, or blood clot in the last 4 weeks.I am not on cancer treatment drugs, but I may be on hormone therapy for other reasons.I have fully healed from any major surgery at least 1 month ago, or from minor surgery at least 10 days ago, with no ongoing complications.
- Group 1: Dose Finding Regorafenib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 is the estimated size of this scientific research sample?
"Affirmative. Evidence from clinicaltrials.gov indicates that this medical trial is currently looking for participants, which was initially posted on March 22nd 2022 and revised May 17th of the same year. 40 individuals must be recruited across 5 distinct sites."
What conclusions is this investigation aiming to reach?
"This trial is designed to measure the incidence of treatment-related adverse events over a period extending up until disease progression or two years (whichever comes first). As secondary outcomes, Disease Control Rate, Overall Response and Overall Survival will be evaluated based on RECIST Version 1.1 criteria."
In how many sites is this trial supervised?
"Currently, 5 sites are running this trial: Overland Park, Lee's Summit and Kansas City along with an additional 5. For participants' convenience, it is advised to choose the locality closest them in order to reduce travel-related stressors."
Can you provide a comprehensive overview of the historical research conducted on Regorafenib?
"Regorafenib was initiated in research at City of Hope a full decade ago, and since then 188 trials have concluded. As we speak, 386 active studies are being conducted with many hosted by the Overland Park clinic in Kansas."
Is there any availability for enrolment in this investigation?
"Affirmative. The clinicaltrials.gov page illustrates that this experiment is recruiting individuals at present, which was posted on March 22nd 2022 and last refreshed on May 17th 2022. A total of 40 patients need to be enrolled from 5 separate sites."
How is Regorafenib usually employed in a clinical setting?
"For those previously treated with anti-VEGF, Regorafenib is the most widely used medication. This drug has additionally been proven effective at managing advanced directives and treating both sorafeninb and metastatic colorectal cancer (CRC)."
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