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Durvalumab + Tremelimumab after DEB-TACE for Liver Cancer
Study Summary
This trial will test a new cancer treatment involving two drugs and a medical procedure. The goal is to see if it is safe and effective for people with liver cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 80 Patients • NCT03015129Trial Design
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Who is running the clinical trial?
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- I have had cancer spread to the lining of my brain and spinal cord.I haven't taken immunosuppressive drugs in the last 14 days.I have had another type of cancer.I experience significant numbness or pain in my hands or feet.I have not had cancer treatment in the last 30 days.I have not had liver-related brain issues or needed medicine for it in the last year.I have had fluid build-up in my abdomen within the last 6 weeks.I have no medical reasons preventing me from undergoing embolization.I have an active skin condition.My liver cancer has spread within the liver or beyond.I have not received a live vaccine in the last 30 days.I am not pregnant or breastfeeding.I have previously been treated with specific immunotherapies in a study.I am 18 years old or older.My condition responds to a specific liver cancer treatment.I weigh more than 30 kilograms.I weigh less than 30 kg.I do not have any severe illnesses that my doctors are still trying to get under control.My organs are functioning well according to specific lab tests.I have no lasting side effects from previous cancer treatments.I have been recently diagnosed with liver cancer.I have not had major surgery within the last 28 days.I am fully active or restricted in physically strenuous activity but can do light work.I have a history of bleeding disorders.I am willing to have a liver biopsy.I have a serious heart condition.I do not have an active infection like TB, HIV, or hepatitis.I have an underactive thyroid.
- Group 1: Durvalumab in combination with Tremelimumab (Cohort A dose)
- Group 2: Durvalumab in combination with Tremelimumab (Cohort B dose)
- 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
Has Durvalumab been given the green light for utilization by the Food and Drug Administration?
"Based on our internal assessment, the safety of Durvalumab was graded a 2 due to pre-existing clinical evidence that supports its security. Unfortunately, there is currently no data available to demonstrate efficacy."
Are any individuals aged eighty-five or older admitted to this investigation?
"This trial seeks to recruit participants in the age range of 18-75 years. For patients below this lower limit, there are 91 clinical trials available and for those above it, 2923 medical studies have been posted."
How many individuals are actively taking part in this experiment?
"Affirmative. The clinical trial registry on clinicialtrials.gov showcases that this study, which was posted October 2nd 2019, is seeking participants at the moment. The project needs to enlist 30 individuals from a single medical centre."
Am I eligible to participate in this experiment?
"This clinical study seeks 30 individuals aged 18 to 75 with liver carcinoma. To be eligible, prospective patients must fulfill the requirements of a signed informed consent form, have measurable disease that responds to DEB-TACE treatment, an ECOG performance status between 0 and 1, body weight over 30kg, evidence of ascites scoring below 7 on radiographic tests, as well as adequate organ function defined by laboratory analysis. Furthermore, women must provide proof of postmenopausal status or negative pregnancy test results."
Is the recruitment for this clinical trial ongoing?
"According to clinicaltrials.gov, this experiment is still seeking participants. It was first advertised on October 2nd of 2019 and has most recently been updated on the 6th of October 2022."
What has Durvalumab been indicated for in clinical practice?
"Durvalumab is widely used to treat advanced, inoperable stage III non-small cell lung cancer and also has some success with metastatic ureteral carcinoma as well other malignancies."
Could you elucidate any other trials that have been conducted using Durvalumab?
"Presently, 340 clinical trials researching Durvalumab are ongoing with 52 in the final phase. While Cordoba, Texas has a notably high concentration of these studies, there are over 13 thousand sites across the world conducting research for this medication."
Is this trial a revolutionary exploration into medical treatment?
"Currently, 340 clinical trials involving Durvalumab are ongoing in 1327 cities and 58 nations. The first trial of this drug was conducted by AstraZeneca back in 2007 with 37 participants; since then 123 follow-up studies have been done to reach Phase 2 approval status."
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