37 Participants NeededMy employer runs this trial

Cadonilimab + Chemotherapy for Stomach Cancer

Recruiting at 6 trial locations
YJ
DM
Overseen ByDaniela Molena, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding cadonilimab to standard chemotherapy enhances treatment effectiveness and safety for individuals with certain types of stomach or gastroesophageal junction cancer. Cadonilimab, an experimental drug, is combined with chemotherapy to determine if it shrinks tumors more effectively than chemotherapy alone. Individuals with HER2-negative stomach cancer that can be surgically removed and who have not received previous cancer treatments may be suitable for this study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant advancements in cancer treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on high doses of corticosteroids or immunosuppressive medications, you may not be eligible to participate.

Is there any evidence suggesting that cadonilimab is likely to be safe for humans?

Research shows that cadonilimab, when combined with chemotherapy, is generally well-tolerated by patients with stomach and gastroesophageal junction (GEJ) cancer. Studies have found that the most common side effects include nausea, vomiting, and low white blood cell counts, known as neutropenia and leukopenia. Specifically, about 72% of patients experienced nausea, 60% had vomiting, 51% had neutropenia, and 45% had leukopenia.

Importantly, recent studies have not identified any new long-term side effects. This indicates that the safety profile of cadonilimab remains consistent over time, with no unexpected side effects emerging later. For those considering participation in a clinical trial, these findings suggest that while cadonilimab has some side effects, they are known and manageable.12345

Why do researchers think this study treatment might be promising?

Cadonilimab is unique because it combines the power of an antibody with the precision of immune checkpoint inhibition. Unlike traditional chemotherapy and HER2-targeted therapies for stomach cancer, Cadonilimab targets specific proteins involved in immune regulation, helping the body's own immune system fight the cancer more effectively. Researchers are excited about this treatment because it offers a new mechanism of action that could improve outcomes for patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma, potentially leading to better survival rates and fewer side effects.

What evidence suggests that cadonilimab plus chemotherapy might be an effective treatment for stomach cancer?

Research has shown that cadonilimab, when combined with chemotherapy, can extend the lives of patients with advanced stomach and gastroesophageal junction (GEJ) cancer. One study found that patients receiving cadonilimab and chemotherapy lived an average of 13.9 months, compared to 11.1 months for those receiving a placebo with chemotherapy. Another study reported even longer survival for patients treated with cadonilimab, with an average of 14.1 months. Additionally, cadonilimab significantly extends the time patients live without their cancer worsening. In this trial, participants with HER2-negative gastric or GEJ adenocarcinoma will receive cadonilimab combined with chemotherapy, exploring its potential as a promising treatment for this specific cancer type.12356

Who Is on the Research Team?

YJ

Yelena Janjigian, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with locally advanced or resectable stomach cancer or gastroesophageal junction (GEJ) cancer. Participants should be healthy enough for chemotherapy and surgery, and not have other serious health issues that could interfere with treatment.

Inclusion Criteria

I am 18 years old or older.
I am able to understand and sign a consent form.
My hemoglobin level is at least 9.0 g/dL.
See 13 more

Exclusion Criteria

I have previously received anti-PD1 or anti-CTLA4 antibody treatment.
My cancer is not adenocarcinoma; it is another type like squamous or neuroendocrine.
My tumor is HER2-positive based on lab tests.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cadonilimab combined with FLOT chemotherapy

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cadonilimab

Trial Overview

The study is testing if adding cadonilimab, an immune therapy drug, to standard chemotherapy works better and is safe compared to chemotherapy alone in people with certain stomach or GEJ cancers.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Participants with HER2-negative gastric or GEJ adenocarcinomaExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Citations

Efficacy and safety of cadonilimab combined with ... - PMC

This study aimed to evaluate the efficacy and safety profile of cadonilimab in combination with chemotherapy for gastric adenocarcinoma and gastroesophageal ...

Cadonilimab Plus Chemo Retains Clinically Meaningful ...

Cadonilimab plus XELOX improved median OS to 13.9 months vs 11.1 months with placebo plus XELOX in advanced gastric/GEJ adenocarcinoma.

Akeso updated 2-year data from cadonilimab combined ...

Remission was efficient in the all-comers. Median OS was 17.41 months, median progression-free survival (PFS) was 9.2 months,

Cost-effectiveness analysis of first-line cadonilimab plus ...

The analysis encompassed the overall CAD-CHM. CAD-CHM is not cost-effective as a first-line treatment for HER2-negative advanced G/GEJ adenocarcinoma,

Cadonilimab (PD-1/CTLA-4) Phase III Data for First Line ...

Cadonilimab combined with chemotherapy regimen significantly improves overall survival benefits for the entire population of advanced gastric cancer patients.

Efficacy and Safety of Cadonilimab Combined with ...

The most frequently reported adverse events included nausea (72%), vomiting (60%), neutropenia (51%), and leukopenia (45%).