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Atezolizumab + Bevacizumab for Liver Cancer
Study Summary
This trial will test whether a combination of two drugs can help treat liver cancer in patients who are eligible for transplantation. The drugs will be given for six months before the transplant procedure.
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.Trial Design
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- You are expected to live for at least 6 more months.You are expected to live for at least 6 months.I am eligible for a liver transplant.I haven't had any cancer except skin cancer in the last 5 years.I am currently on medication for hepatitis B.I have a history of neurological issues, like seizures, not caused by cancer but treated with medication.I have not had a live vaccine in the last 4 weeks and don't plan to during or within 5 months after treatment.I don't have any health issues that would make it unsafe for me to take a new drug.I have been tested for hepatitis B and either do not have it or it is not active.I have had treatment for liver cancer before joining this study.My liver cancer is confirmed and hasn't spread outside the liver. I may provide a biopsy.I have had a severe blood clot in the past.I have had or am planning to have a transplant involving multiple organs or a stem cell transplant.I have previously been treated with specific immune therapies.I have active tuberculosis.I had radiation therapy before, but my cancer has returned or spread.I haven't had stomach or bowel inflammation in the last 6 months.I use NSAIDs daily for a chronic condition, but not just for occasional pain or fever.My liver functions well enough for treatment.I have had treatment for painful cancer spread and have recovered from it.I have a bleeding disorder that increases my risk of bleeding.I have had lung conditions like pulmonary fibrosis or pneumonia, but not due to radiation.I am fully active or can carry out light work.I have not taken high doses of aspirin or clopidogrel recently and if on anticoagulants, my levels are stable.I haven't taken strong immune system medications in the last 2 weeks.I don't have active autoimmune diseases except for controlled hypothyroidism or mild skin conditions.I have pain from my cancer that isn't relieved by treatment.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.My recent blood tests meet the study's health requirements.I agree to use effective birth control or remain abstinent during and 6 months after treatment.I have not had major surgery or significant injury in the last 28 days and do not expect to need major surgery during the study.I have had an EGD for varices within the last 6 months or will have one before joining the study.I have had a severe hypertension crisis or brain issues due to high blood pressure.I haven't had a severe infection or been hospitalized for one in the last 4 weeks.I have had cancer spread to the lining of my brain and spinal cord.My liver cancer is confirmed and hasn't spread outside the liver. I may provide a biopsy sample.My liver function is good.I have not coughed up a significant amount of blood recently.I haven't had a biopsy or minor surgery (except for a vascular access device) in the last 7 days.My calcium levels are normal and not causing symptoms.I had radiation therapy before, but my cancer has returned or spread.I am not allergic to Atezlizumab, Bevacizumab, or Chinese hamster ovary cell products.I frequently need procedures to remove excess fluid from my body.I haven't had major heart issues or strokes in the last 3 months.I have moderate to severe fluid buildup in my abdomen.I have not needed IV antibiotics for an infection in the last 2 weeks.I don't have severe varices and had an EGD test within the last 6 months.My liver cancer can be measured or evaluated by specific criteria and cannot be surgically removed.I haven't had major blood vessel issues like aneurysms or clots in the last 6 months.I haven't had serious stomach or intestine issues, like bleeding or abscesses, in the last 6 months.Your body has enough infection-fighting white blood cells, with a count of at least 1.5 x 10^9/L.My liver cancer is a specific type: fibrolamellar, sacromatoid, or mixed with bile duct cancer.I am a candidate for and can undergo TACE procedures.I am 18 years old or older.I have had episodes of brain confusion due to liver problems.My liver cancer can be measured or evaluated by specific criteria and cannot be surgically removed.I am fully active or can carry out light work.I am eligible for a liver transplant.I have a serious wound or bone fracture that hasn't healed.I am 18 years or older and can sign a consent form.I am a candidate for and can undergo TACE procedures.
- Group 1: Atezolizumab + Bevacizumab
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Is recruitment open for this research project?
"Clinicaltrials.gov suggests that this research project is not currently recruiting patients, as the trial was most recently updated on January 5th 2022 after being initially posted on March 17th 2022. Although no longer enrolling volunteers for this study, 2739 other clinical trials are actively seeking participants right now."
Has the combination of Atezolizumab and Bevacizumab been given the green light by the FDA?
"With Phase 4 trials already conducted and approved, the safety of Atezolizumab + Bevacizumab was deemed a 3 on our team's evaluation scale."
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