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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

22%

vitreous hemorrhage

17%

worsening of cataract

posterior capsule opacification

vitreous syneresis

cranial nerve VI palsy

pneumonia

pyelonephritis

colon cancer

bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

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