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Platinum-containing Compound
Chemotherapy + Atezolizumab for Advanced Liver Cancer
Phase 2
Recruiting
Led By David Hsieh
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have disease which is unresectable or metastatic
Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing the addition of immunotherapy and bevacizumab (a cancer blood vessel growth inhibitor) to standard chemotherapy in patients with advanced liver cancer.
Who is the study for?
Adults with advanced liver cancer that can't be surgically removed or has spread, who've completed certain treatments over 4 weeks ago. They must have adequate blood counts and organ function, not be pregnant/breastfeeding, free from autoimmune diseases or immune deficiencies (with some exceptions), and without a history of severe allergies to trial drugs.Check my eligibility
What is being tested?
The study is testing if adding Bevacizumab (an antiangiogenic agent) to the combination of Chemotherapy (Gemcitabine and Cisplatin) and Atezolizumab (a monoclonal antibody immunotherapy) is more effective in treating unresectable or advanced liver cancer than just Chemotherapy with Atezolizumab.See study design
What are the potential side effects?
Possible side effects include high blood pressure, bleeding risks, pain management issues, potential for infection like tuberculosis, lung problems such as pneumonitis, allergic reactions to drug components. Immunosuppressive medications are also excluded due to increased risk of complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer cannot be removed by surgery or has spread to other parts of my body.
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I am fully active or can carry out light work.
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My liver cancer shows both HCC and CC characteristics.
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My liver cancer is not purely one type but a mix, without being a clear case of HCC or CC.
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My diagnosis is combined liver and bile duct cancer, as confirmed by lab tests.
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My cancer spot has grown more than 25% or wasn't treated with targeted therapy.
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I have hepatitis B and have been on suppressive therapy for at least 2 weeks.
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I am 18 years old or older.
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My liver function is mildly affected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Objective response rate
Overall response rate
Side effects data
From 2015 Phase 4 trial • 45 Patients • NCT0203642422%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (atezolizumab, bevacizumab, gemcitabine, cisplatin)Experimental Treatment7 Interventions
Patients receive atezolizumab IV over 30-60 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV on days 1 and 8. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the trial. Patients undergo blood specimen collection on study.
Group II: Arm B (atezolizumab, gemcitabine, cisplatin)Active Control6 Interventions
Patients receive atezolizumab IV over 30-60 minutes on day 1, and gemcitabine IV over 30 minutes and cisplatin IV on days 1 and 8. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or magnetic resonance imaging MRI throughout the trial. Patients undergo blood specimen collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Atezolizumab
2017
Completed Phase 3
~5860
Computed Tomography
2017
Completed Phase 2
~2720
Bevacizumab
2013
Completed Phase 4
~5280
Biospecimen Collection
2004
Completed Phase 2
~1700
Cisplatin
2013
Completed Phase 3
~1940
Conventional Magnetic Resonance Imaging
2021
N/A
~20
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,664 Previous Clinical Trials
40,925,918 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
David HsiehPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any bleeding disorders or significant blood clotting issues.My cancer cannot be removed by surgery or has spread to other parts of my body.My hemoglobin level is at least 9 g/dL, possibly after a transfusion.My white blood cell count is healthy for treatment.I am fully active or can carry out light work.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.I have skin conditions like eczema or psoriasis without any related arthritis.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.I haven't had any major gut or throat complications in the last 6 months.I have cancer spread that might cause pain or disability but hasn't yet, and I'm considered for targeted therapy before joining the trial.I've only had short-term immunosuppressants, like a quick steroid dose for an allergy.I am HIV positive, on treatment, and my viral load is undetectable.I am taking steroids for asthma, COPD, low blood pressure, or adrenal issues.I've had or will have an EGD to check for risky varices before joining the study.My liver cancer shows both HCC and CC characteristics.My condition is stable with mild treatment.I do not have any autoimmune diseases or immune deficiencies.I have type 1 diabetes that is managed with insulin.My cancer-related pain is under control with a stable pain medication regimen.I do not need frequent procedures to remove excess fluid from my body.I do not have active hepatitis B or C infections.I have an autoimmune thyroid condition but am on medication for it.My liver cancer is not purely one type but a mix, without being a clear case of HCC or CC.My blood pressure is under control, below 150/100 mmHg, with or without medication.I haven't needed strong treatments for flare-ups of my condition recently.My recent kidney function test shows creatinine levels within the normal range.My diagnosis is combined liver and bile duct cancer, as confirmed by lab tests.My cancer spot has grown more than 25% or wasn't treated with targeted therapy.I am not allergic to any part of the atezolizumab or bevacizumab treatments.I am not on, nor do I need, drugs that weaken my immune system.I haven't had major blood vessel problems like aneurysms or clots in the last 6 months.I don't have any health conditions that would make the study's treatment unsafe for me.I do not have new or worsening brain tumors or cancer in the lining of my brain.I will not try to conceive and will use effective birth control during and for 6 months after treatment.I have never been treated with immune checkpoint inhibitors.I have hepatitis B and have been on suppressive therapy for at least 2 weeks.I am capable of becoming pregnant based on my medical history and current health status.I am 18 years old or older.I haven't had major surgery in the last 4 weeks and don't expect any during the study.You cannot be pregnant or breastfeeding because the treatment could harm your baby or cause adverse effects.My cancer can be measured and was checked within the last 4 weeks.My blood clotting time is within the normal range, or I am on a stable blood thinner regimen.I finished palliative radiotherapy over a week ago, and the treated area is not the target lesion.My rash covers less than 10% of my body.I do not have active tuberculosis.I had treatment targeting a specific area of my cancer.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I have never had systemic therapy for cHCC-CC.I haven't had any live vaccines in the last 4 weeks and won't during or for 5 months after my atezolizumab treatment.I have never had lung inflammation not caused by infections.I am not allergic to any ingredients in atezolizumab or similar products.Your medical records showing the type of disease you have are enough to enroll you in the study and receive treatment.I have had radiation for painful cancer spread and have recovered from it.My liver function is mildly affected.I completed treatments like surgery or radiation for my cancer more than 4 weeks ago.I have another cancer type, but it won't affect this trial's treatment.I have not had a bone marrow or organ transplant from another person.You cannot have had a severe allergic reaction to chimeric or humanized antibodies or fusion proteins in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (atezolizumab, bevacizumab, gemcitabine, cisplatin)
- Group 2: Arm B (atezolizumab, gemcitabine, cisplatin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are Bevacizumab's well-documented effects on people?
"While there is some data backing Bevacizumab's safety, it did not yet receive a rating higher than 2."
Answered by AI
At how many hospitals or research facilities is this investigation being carried out?
"There are 20 enrolling patients for this study at various locations, such as Sutter Auburn Faith Hospital in Auburn, Sutter Medical Center Sacramento in Sacramento, and Alta Bates Summit Medical Center-Herrick Campus in Berkeley."
Answered by AI
How many test subjects are in this experiment?
"That is correct. The clinicaltrials.gov website currently lists this study as active and recruiting participants. 20 medical sites are enrolling a total of 88 patients for the study, which was originally posted on February 11th, 2022."
Answered by AI
Is this study presently seeking participants?
"This study is recruiting participants, as indicated on clinicaltrials.gov. The trial was first posted on February 11, 2022 and was last updated on October 29, 2022."
Answered by AI
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