Nab-paclitaxel combined with cadonilimab (AK104) as second-line treatment for advanced gastric cancer: protocol for a phase II prospective, multicenter, single-arm clinical trial

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Overview of the Study

This study focuses on advanced gastric cancer (GC), a common and serious cancer with a poor outlook. Current treatments, like paclitaxel and nab-paclitaxel, are often not very effective. Researchers are exploring new combinations of treatments to improve patient outcomes.

What is Being Tested?

The study is testing a new combination of nab-paclitaxel and a drug called cadonilimab (AK104). This combination is being used as a second-line treatment for patients who did not respond to initial therapy that included immune checkpoint inhibitors (ICIs).

Study Details

This is a Phase II clinical trial that involves multiple centers. Patients aged 18-75, who have advanced GC and have not responded to previous treatments, will be eligible. They will receive:

  • Cadonilimab (AK104) every two weeks
  • Nab-paclitaxel every four weeks

Goals of the Study

The main goal is to see how effective this combination is at shrinking tumors (objective response rate). Other goals include:

  • Understanding how long the treatment keeps the cancer from worsening (progression-free survival)
  • Determining overall survival rates

Importance of Biomarkers

The study will also look for specific markers in patients’ blood that could predict how well they will respond to treatment. Identifying these markers can help tailor treatments to individual patients.

Expected Outcomes

The study hopes to improve treatment options for patients with advanced GC by:

  • Reactivating the body’s immune response against cancer
  • Providing insights into how to better manage and treat this disease

Next Steps for Implementation

Clinics can start by implementing this treatment in a controlled manner, tracking results and adapting as necessary. The trial results will guide further use of this combination therapy in real-world settings.

Contact for More Information

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