What side effects are associated with this type of intervention?

Common treatments for liver cancer, such as Tyrosine Kinase Inhibitors (e.g., Telatinib) and Immune Checkpoint Inhibitors (e.g., Keytruda), have distinct side effect profiles. TKIs often cause hypertension, hand-foot skin reactions, diarrhea, fatigue, and liver dysfunction. ICIs can lead to immune-related adverse events including colitis, hepatitis, pneumonitis, endocrinopathies, and skin reactions. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

For the treatment of liver cancer, the FDA has approved several tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs). Sorafenib (Nexavar), a TKI that inhibits RAF kinase and VEGFR, was established as a standard systemic treatment for advanced hepatocellular carcinoma (HCC). Lenvatinib (Lenvima), another TKI, has also been approved for first-line treatment of unresectable HCC. In the realm of ICIs, Atezolizumab (Tecentriq) combined with Bevacizumab (Avastin) has shown significant efficacy and received approval for unresectable HCC. These treatments are similar to the investigational combination of Telatinib (a TKI targeting VEGFR) and Keytruda (an ICI targeting PD-1) being studied in clinical trials.

What other types of research exist?

Promising novel alternatives for liver cancer treatment in 2024 include: 1) Lenvatinib, a TKI that has shown efficacy in combination with transarterial chemoembolization (TACE) in advanced HCC. 2) Atezolizumab (an ICI targeting PD-L1) combined with Bevacizumab (an anti-VEGF antibody), which has demonstrated improved outcomes in high-risk HCC post-resection or ablation. 3) Durvalumab (an ICI targeting PD-L1) combined with Tremelimumab (an anti-CTLA-4 antibody), which has shown activity in unresectable HCC.

← Back to Search

PD-1 Inhibitor

Telatinib + Keytruda for Stomach and Liver Cancer

Phase 2

Waitlist Available

Led By Andrew Hendifar, MD, MPH

Research Sponsored by Andrew Hendifar, MD

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 through study completion, approximately 2.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, telatinib and Keytruda, in patients with advanced stomach, gastroesophageal junction cancer, and liver cancer. Telatinib aims to stop cancer growth, while Keytruda helps the immune system fight the cancer. The goal is to see if this combination can help patients live longer without their cancer worsening.

Who is the study for?

Adults with advanced stomach, gastroesophageal junction cancers or hepatocellular carcinoma that have progressed after prior treatments and are PD-L1-positive. They must be able to swallow tablets, not have uncontrolled infections or certain other health conditions, and agree to use contraception.

What is being tested?

The trial is testing the combination of Telatinib and Keytruda in patients with specific advanced cancers. It's an open-label study focusing on how these drugs affect the time a patient lives without their disease getting worse.

What are the potential side effects?

Possible side effects include high blood pressure, bleeding events, nonhealing wounds or ulcers, gastrointestinal issues like fistulas or perforations, liver problems due to hepatitis B or cirrhosis, immune system complications including pneumonitis and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, approximately 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, approximately 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 2.5 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

Secondary study objectives

Disease Control Rate

Number and Severity of Adverse Events

Overall Response Rate

+1 more

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: telatinib + KeytrudaExperimental Treatment2 Interventions

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 tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs). TKIs, such as sorafenib and lenvatinib, inhibit kinases like VEGFR, which are essential for tumor angiogenesis, thereby reducing the tumor's blood supply and growth. ICIs, like Keytruda (pembrolizumab), target PD-1 on T cells, preventing the inhibition of the immune response and enhancing the body's ability to attack cancer cells. These treatments are crucial for liver cancer patients as they provide targeted strategies to impede tumor progression and boost immune-mediated tumor eradication, potentially improving patient outcomes.

A Single Nucleotide Mixture Enhances the Antitumor Activity of Molecular-Targeted Drugs Against Hepatocellular Carcinoma.Angiogenesis Inhibitors for the Treatment of Hepatocellular Carcinoma.