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Sorafenib + Nivolumab for Liver Cancer
Study Summary
This trial is testing a combination of two drugs to treat patients 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 2020 Phase 2 trial • 40 Patients • NCT01900002Trial Design
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- You can be diagnosed using medical imaging if you meet specific criteria set by the American Association for the Study of Liver Diseases.I had minor surgery or a biopsy at least a week ago and have mostly recovered.I had palliative radiation at least 2 weeks ago and have mostly recovered.I agree to use two forms of birth control for 5 months after my last dose, and my male partner agrees to do the same for 7 months.My cancer is a specific type called fibrolamellar or mixed HCC-cholangiocarcinoma.I have had brain symptoms from liver disease needing medication or hospitalization in the last 6 months.I have both hepatitis B and either hepatitis D or C.My cancer has spread to the lungs and shows central or necrotic features.I need medication to prevent blood clots.I am not pregnant or breastfeeding.It's been over 6 weeks since my major surgery and I've mostly recovered.My liver cancer cannot be removed by surgery or cured with other treatments.I have a tumor that can be measured on scans and hasn't been treated with specific local procedures.My organs and bone marrow are functioning well.I only use steroids for adrenal issues, short asthma attacks, or as premeds for contrast dye.I have cancer that has spread to my brain or its coverings.I do not have any ongoing serious illnesses that are not under control.You have a known or suspected allergy or sensitivity to any of the drugs or ingredients used in this study.My liver cancer cannot be removed or cured with surgery or other treatments.It's been over 4 weeks since my last local cancer treatment and I've mostly recovered.I am 18 years old or older.My liver functions are within the required range for the study.I do not have serious heart conditions like recent heart attacks or severe heart failure.I have at least one cancer spot that can be measured and hasn't been treated locally.I have no other cancers except possibly some treated skin, prostate, bladder cancers, or cervical cancer in-situ.It's been over 4 weeks since my last local cancer treatment and I've mostly recovered.I can follow the study plan and attend all required check-ups.I am taking medication to suppress my immune system due to an autoimmune condition.I have signed the consent form for this study.I needed a procedure to remove excess belly fluid in the last 6 months.I have had bleeding from my esophagus or stomach in the last year.The research team needs a sample of your tumor tissue from a previous biopsy or surgery for further testing.My blood tests show enough neutrophils, platelets, and hemoglobin.I haven't had a stroke, heart attack, or deep vein clot in the last 6 months.I have cirrhosis or varices and have undergone the recommended endoscopy treatments.My blood pressure is 140/90 or lower, with or without medication.My liver function is moderately impaired.I am on antiviral therapy for HBV with a viral load under 500 IU/mL.I had palliative radiation at least 2 weeks ago and have recovered with minimal side effects.I haven't taken strong CYP3A4 inducers in the last 28 days.I have seizures due to a brain condition and need medication.If you have not received a tissue or cell diagnosis, you may still be eligible if your radiographic results meet the American Association for the Study of Liver Diseases criteria for diagnosis.I am fully active or restricted in physically strenuous activity but can do light work.I have available tumor tissue from before any treatment.I have had a transplant of an organ or bone marrow.I am HIV positive.I am a woman who can have children and have a negative pregnancy test from the last 28 days.I am fully active or restricted in physically strenuous activity but can do light work.I am 18 years old or older.It's been over 6 weeks since my major surgery and I've mostly recovered.I can swallow and keep down pills.I have symptoms of low thyroid hormone levels and am not taking medication for it.My blood pressure is not controlled despite taking medication.I haven't had serious lung bleeding or any other severe bleeding in the last 6 months.I have received treatment for liver cancer before.I have not had any non-healing wounds or bone fractures in the last 30 days.The investigator thinks that you are not suitable to participate in the trial because of a health condition.
- Group 1: Part 1: Dose Escalation
- Group 2: Part 2: Child Pugh B Expansion (sorafenib, nivolumab)
- 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 primary aim of this medical research study?
"As communicated by the study sponsor, Bristol-Myers Squibb, primary outcome of this medical trial is Maximum Tolerated Dose (MTD) after two years. The secondary outcomes being assessed include Progression-free Survival (PFS), Proportion of participants with dose delays and Overall Survival (OS). Metrics for PFS are determined from date of first dosage to date of either documented radiographic or clinical disease advancement or death; while OS measures time between initial dosage until eventual demise regardless of cause."
Is Sorafenib a relatively risk-free treatment option?
"There is a limited amount of data indicating the safety of Sorafenib, so it received score 2."
To what extent is participation in this study limited?
"Confirmed. According to the information posted on clinicaltrials.gov, this trial is actively seeking 24 individuals for its two sites since it was first introduced in April 16th 2018 and last updated on May 31st 2022."
Is the study still welcoming new participants?
"Correct. Per the records found on clinicaltrials.gov, this medical trial commenced recruitment on April 16th 2018 and is still ongoing as of May 31st 2022. There are currently 24 spots available across 2 sites for qualified participants to join in."
Has Sorafenib been employed in any previous research projects?
"Currently, 772 clinical studies are underway concerning Sorafenib. Out of these trials, 101 have reached Phase 3 with the majority located in Taibei, Taiwan and 42064 other sites across the globe."
To what diseases is Sorafenib commonly employed?
"Sorafenib is commonly prescribed to treat metastatic ureter urothelial carcinoma and can also help manage conditions such as malignant skin melanoma, metastatic hepatocellular carcinoma, and those who have already been through anti-angiogenic therapy."
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