What side effects are associated with this type of intervention?

Common treatments for liver cancer, such as intra-arterial (IA) therapy, transarterial chemoembolization (TACE), and systemic treatments like sorafenib, have various side effects. IA therapy and TACE can cause post-embolization syndrome, characterized by pain, fever, nausea, and vomiting. Sorafenib, a systemic treatment, is associated with hand-foot skin reactions, diarrhea, fatigue, and abnormal hepatic function. Serious adverse events, although rare, include severe hepatic dysfunction and drug-related deaths.

What prior FDA approvals exist?

The FDA has approved several treatments for liver cancer, particularly for advanced hepatocellular carcinoma (HCC). Sorafenib (Nexavar) was one of the first systemic treatments approved, showing improved survival in advanced HCC. Lenvatinib (Lenvima) is another systemic therapy approved as a first-line treatment for unresectable HCC. Additionally, transarterial chemoembolization (TACE) is a liver-directed therapy commonly used for intermediate-stage HCC, although its combination with systemic therapies like sorafenib has shown mixed results. These treatments aim to target the tumor's blood supply, similar to the selective tumor blood vessel blockade being studied in the new IA therapy trial.

What other types of research exist?

Promising alternatives to the new agent for IA therapy in liver cancer include the combination of atezolizumab and bevacizumab, which has significantly improved overall survival and progression-free survival compared to sorafenib. Additionally, transarterial chemoembolization (TACE) combined with sorafenib has shown effectiveness and good tolerance in patients with unresectable hepatocellular carcinoma.

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Virus Therapy

IA Therapy for Liver Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for liver cancer include intra-arterial (IA) therapy, anti-angiogenic drugs, targeted therapies, and immune checkpoint inhibitors. IA therapy works by blocking the blood supply to the tumor, causing tumor cell death due to lack of nutrients and oxygen. Anti-angiogenic drugs inhibit the formation of new blood vessels that supply the tumor, effectively starving it. Targeted therapies, such as tyrosine kinase inhibitors, block specific molecules involved in tumor growth and progression. Immune checkpoint inhibitors enhance the body's immune response against cancer cells. These mechanisms are crucial for liver cancer patients as they offer multiple strategies to disrupt tumor growth and improve survival outcomes. The new agent for IA therapy, which selectively blocks tumor blood vessels, represents an advancement by potentially reducing damage to normal liver tissue while effectively targeting the tumor.

Phase < 1

Recruiting

Research Sponsored by Koo Foundation Sun Yat-Sen Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up by mri on day 50 and then every 3 months for an average of one year.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new protein treatment for patients with inoperable liver cancer. The treatment targets and blocks the blood vessels feeding the cancer, cutting off its blood supply and causing it to die.

Who is the study for?

Adults diagnosed with intermediate-stage B or limited advanced-stage C liver cancer (HCC) who are not candidates for curative surgery, liver transplant, or ablation. They should have an ECOG performance status of ≤1, indicating they are fully active or restricted in physically strenuous activity but ambulatory and able to carry out work of a light nature. Participants must have adequate organ function as shown by specific blood tests and agree to use effective contraception.

What is being tested?

The trial is testing a new intra-arterial therapy called CSR02-Fab-TF specifically targeting the blood vessels feeding HCC tumors while sparing normal liver tissue. This approach aims to cut off the tumor's blood supply more selectively than current methods, potentially leading to better outcomes for patients with extensive tumors not suitable for surgical removal.

What are the potential side effects?

While the trial description does not list specific side effects, similar treatments can cause complications like fever, abdominal pain, nausea, changes in liver function tests, and potential allergic reactions to contrast media used during IA procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ by mri on day 50 and then every 3 months for an average of one year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~by mri on day 50 and then every 3 months for an average of one year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and by mri on day 50 and then every 3 months for an average of one year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HCC blood flow

Incidence and severity of adverse events from intra-arterial infusion of CSR02-Fab-TF in patients with hepatoma only or largely confined to the liver, and resistant/recurrent after prior therapy

Secondary study objectives

Intra-Arterial Infusions

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Investigational ArmExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

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

Common treatments for liver cancer include intra-arterial (IA) therapy, anti-angiogenic drugs, targeted therapies, and immune checkpoint inhibitors. IA therapy works by blocking the blood supply to the tumor, causing tumor cell death due to lack of nutrients and oxygen. Anti-angiogenic drugs inhibit the formation of new blood vessels that supply the tumor, effectively starving it. Targeted therapies, such as tyrosine kinase inhibitors, block specific molecules involved in tumor growth and progression. Immune checkpoint inhibitors enhance the body's immune response against cancer cells. These mechanisms are crucial for liver cancer patients as they offer multiple strategies to disrupt tumor growth and improve survival outcomes. The new agent for IA therapy, which selectively blocks tumor blood vessels, represents an advancement by potentially reducing damage to normal liver tissue while effectively targeting the tumor.

Systemic Therapy for Hepatocellular Carcinoma: Chinese Consensus-Based Interdisciplinary Expert Statements.Combination approaches in hepatocellular carcinoma: How systemic treatment can benefit candidates to locoregional modalities.