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Platinum-containing Compound
Chemotherapy + Atezolizumab for Advanced Liver Cancer
Phase 2
Waitlist Available
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
Must not have
Patient must not have any evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
Patient may not have a history of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
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.
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.
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.
Select...
My liver cancer is not purely one type but a mix, without being a clear case of HCC or CC.
Select...
My diagnosis is combined liver and bile duct cancer, as confirmed by lab tests.
Select...
My cancer spot has grown more than 25% or wasn't treated with targeted therapy.
Select...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any bleeding disorders or significant blood clotting issues.
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I haven't had any major gut or throat complications in the last 6 months.
Select...
My condition is stable with mild treatment.
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I have type 1 diabetes that is managed with insulin.
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My cancer-related pain is under control with a stable pain medication regimen.
Select...
I do not have active hepatitis B or C infections.
Select...
I have an autoimmune thyroid condition but am on medication for it.
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My blood pressure is under control, below 150/100 mmHg, with or without medication.
Select...
I haven't needed strong treatments for flare-ups of my condition recently.
Select...
I am not allergic to any part of the atezolizumab or bevacizumab treatments.
Select...
I haven't had major blood vessel problems like aneurysms or clots in the last 6 months.
Select...
I do not have new or worsening brain tumors or cancer in the lining of my brain.
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I will not try to conceive and will use effective birth control during and for 6 months after treatment.
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I have never been treated with immune checkpoint inhibitors.
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I haven't had major surgery in the last 4 weeks and don't expect any during the study.
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My rash covers less than 10% of my body.
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I do not have active tuberculosis.
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I have never had systemic therapy for cHCC-CC.
Select...
I have never had lung inflammation not caused by infections.
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I am not allergic to any ingredients in atezolizumab or similar products.
Select...
I have not had a bone marrow or organ transplant from another person.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression free survival (PFS)
Secondary study objectives
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%
pneumonia
4%
cranial nerve VI palsy
4%
pyelonephritis
4%
colon cancer
4%
bradycardia
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
Bevacizumab
2013
Completed Phase 4
~5540
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Atezolizumab
2017
Completed Phase 3
~5850
Computed Tomography
2017
Completed Phase 2
~2740
Biospecimen Collection
2004
Completed Phase 3
~2020
Cisplatin
2013
Completed Phase 3
~2360
Conventional Magnetic Resonance Imaging
2021
N/A
~20
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,912 Total Patients Enrolled
105 Trials studying Liver Cancer
26,544 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.
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