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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
No Placebo-Only Group

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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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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.
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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.
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I do not have active hepatitis B or C infections.
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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.
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I haven't needed strong treatments for flare-ups of my condition recently.
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I am not allergic to any part of the atezolizumab or bevacizumab treatments.
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I haven't had major blood vessel problems like aneurysms or clots in the last 6 months.
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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.
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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.
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I have not had a bone marrow or organ transplant from another person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

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 • NCT02036424
52%
increased intraocular pressure
26%
worsening of cataract
15%
posterior capsule opacification
11%
vitreous syneresis
7%
epiretinal membrane
7%
vitreous hemorrhage
5%
choroidal detachment
5%
congestive heart failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ozurdex
Bevacizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2016
Completed Phase 3
~5860
Computed Tomography
2017
Completed Phase 2
~2740
Biospecimen Collection
2004
Completed Phase 3
~2020
Cisplatin
2013
Completed Phase 3
~3120
Conventional Magnetic Resonance Imaging
2021
N/A
~20

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,906 Previous Clinical Trials
41,011,940 Total Patients Enrolled
104 Trials studying Liver Cancer
26,540 Patients Enrolled for Liver Cancer
David HsiehPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Cisplatin (Platinum-containing Compound) Clinical Trial Eligibility Overview. Trial Name: NCT05211323 — Phase 2
Liver Cancer Research Study Groups: Arm A (atezolizumab, bevacizumab, gemcitabine, cisplatin), Arm B (atezolizumab, gemcitabine, cisplatin)
Liver Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT05211323 — Phase 2
Cisplatin (Platinum-containing Compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05211323 — Phase 2
~7 spots leftby Jan 2025