What side effects are associated with this type of intervention?

Common treatments for liver cancer, such as atezolizumab (an anti-PD-L1 antibody) and bevacizumab (an anti-VEGF antibody), have well-documented side effects. Atezolizumab can cause immune-related side effects including fatigue, rash, diarrhea, and liver enzyme abnormalities, with severe reactions like pneumonitis, hepatitis, colitis, and endocrinopathies also possible. Bevacizumab is associated with hypertension, proteinuria, bleeding, thromboembolic events, and gastrointestinal perforations. Combining these agents may increase the risk of these side effects, necessitating close monitoring.

What prior FDA approvals exist?

The FDA has approved several treatments for liver cancer, particularly for advanced hepatocellular carcinoma (HCC). Sorafenib (Nexavar), a multitargeted tyrosine kinase inhibitor, was one of the first systemic therapies approved for unresectable HCC. More recently, the combination of atezolizumab (an anti-PD-L1 antibody) and bevacizumab (an anti-VEGF antibody) has shown promising results and has been approved for the treatment of unresectable HCC. This combination has demonstrated longer progression-free survival compared to atezolizumab alone. These approvals highlight the evolving landscape of liver cancer treatment, incorporating targeted therapies and immunotherapies.

What other types of research exist?

Promising novel alternatives to SRF388 in combination with atezolizumab and bevacizumab for liver cancer patients include: 1) Tremelimumab plus Durvalumab, which has shown efficacy in unresectable HCC. 2) Sorafenib, a well-established treatment for advanced HCC, though typically used as a monotherapy. 3) Lenvatinib, another first-line therapy for advanced HCC, which can be considered in combination with other treatments. These alternatives offer different mechanisms of action and have shown potential in clinical trials.

← Back to Search

Monoclonal Antibodies

Atezolizumab + Bevacizumab +/− SRF388 for Liver Cancer

Phase 2

Waitlist Available

Research Sponsored by Coherus Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child-Pugh Class A disease

No prior systemic treatment for unresectable locally advanced or metastatic HCC

Must not have

Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)

Medical conditions requiring chronic steroid therapy (ie, > 10 mg/day of prednisone or its equivalent) or anticipates the need for systemic immunosuppressive medications during treatment with study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial tests SRF388 with atezolizumab and bevacizumab in patients with advanced liver cancer. The treatment aims to enhance immune response and block blood supply to tumors. Atezolizumab and bevacizumab have become the standard of care for advanced hepatocellular carcinoma, replacing sorafenib which was the standard for over ten years.

Who is the study for?

Adults with advanced liver cancer (Hepatocellular Carcinoma) who haven't had systemic treatment for their condition can join this trial. They should be in relatively good health, able to perform daily activities with ease or slight difficulty, and have a liver that's still working well. Pregnant women can't participate, and those who can have children must use birth control.

What is being tested?

The study is testing the effectiveness of SRF388 combined with Atezolizumab and Bevacizumab versus a placebo mixed with the same two drugs in treating first-line advanced liver cancer. Participants are randomly assigned to one of these groups to compare results.

What are the potential side effects?

Possible side effects include immune system reactions leading to inflammation in various organs, infusion-related responses, increased risk of infections due to weakened immunity, bleeding issues related to Bevacizumab, and general symptoms like fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My liver disease is mild.

Select...

I haven't had any treatments for my advanced liver cancer.

Select...

I am 18 years old or older.

Select...

My liver cancer cannot be removed by surgery and has spread.

Select...

I am fully active or can carry out light work.

Select...

My liver cancer is at an intermediate or advanced stage.

Select...

I have taken a pregnancy test within the last week and it was negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I frequently need procedures to remove excess fluid from my body.

Select...

I am on or might need strong medication to suppress my immune system.

Select...

I have been treated with an anti-IL-27 therapy before.

Select...

I have an active HIV infection.

Select...

My liver cancer is of a specific type (fibrolamellar, sarcomatoid, or mixed with bile duct cancer).

Select...

I have brain metastases or leptomeningeal carcinomatosis that are not treated or causing symptoms.

Select...

My high blood pressure is not well controlled.

Select...

I have had or currently have brain function issues due to liver disease.

Select...

I have moderate to severe fluid buildup in my abdomen.

Select...

I have varices at risk of bleeding that haven't been fully treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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) according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)

Secondary study objectives

Area under the serum concentration-time curve from time zero to the last quantifiable time point (AUC0-last)

Disease Control Rate (DCR)

Duration of Response (DoR) according to HCC mRECIST

+17 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Lead-InExperimental Treatment3 Interventions

A minimum of 6 patients and up to 30 patients will be enrolled in an open-label Lead-In to assess the preliminary safety and tolerability of SRF388 with atezolizumab plus bevacizumab.

Group II: Arm B: Placebo in combination with atezolizumab plus bevacizumabExperimental Treatment3 Interventions

Patients randomized to Arm B will receive placebo with atezolizumab plus bevacizumab.

Group III: Arm A: SRF388 in Combination with atezolizumab plus bevacizumabExperimental Treatment3 Interventions

Patients randomized to Arm A will receive SRF388 with atezolizumab plus bevacizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

FDA approved

Placebo

1995

Completed Phase 3

~2670

Atezolizumab

FDA approved

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Atezolizumab, an anti-PD-L1 antibody, enhances the immune system's ability to attack liver cancer cells by inhibiting the PD-L1 pathway. Bevacizumab, an anti-VEGF antibody, reduces the blood supply to tumors by inhibiting vascular endothelial growth factor (VEGF), thereby inhibiting tumor growth. These mechanisms are crucial for liver cancer patients as they target the tumor's ability to evade the immune system and its blood supply, potentially leading to better control of tumor growth and improved survival outcomes.