Study on Cadonilimab and Chemotherapy for Gastric or Gastroesophageal Junction Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT07631000
This clinical trial is exploring whether adding the drug cadonilimab to standard chemotherapy can be a safe and effective treatment for people with locally advanced gastric or gastroesophageal junction cancer that can be surgically removed.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The aim of this study is to determine if combining cadonilimab with the usual chemotherapy treatment is a safe and effective option for patients with locally advanced gastric or gastroesophageal junction cancer that can be surgically removed. Researchers want to see if this combination can improve treatment outcomes compared to chemotherapy alone.
Eligibility Criteria
Inclusion Criteria
- Able to provide signed consent to participate.
- Aged 18 years or older.
- In good general health, with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Diagnosed with a specific type of gastric or gastroesophageal junction cancer that can be surgically removed.
- Tumor must be HER2-negative.
- Have adequate organ and bone marrow function, including:
- Hemoglobin level of at least 9.0 g/dL.
- Neutrophil count of at least 1.5 x 10^9/L.
- Platelet count of at least 100 x 10^9/L.
- Normal liver function tests, with some exceptions for known conditions like Gilbert's disease.
- Kidney function with creatinine clearance over 50 mL/min.
- Willing to undergo tumor biopsies before and during treatment.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
- Men with partners of childbearing potential must agree to use effective contraception during and after the study.
Exclusion Criteria
- Have a type of cancer other than adenocarcinoma, such as squamous cell carcinoma or neuroendocrine tumors.
- Tumor is HER2-positive.
- Have received any prior treatment for the cancer being studied.
- Have previously received certain types of immunotherapy.
- Have medical conditions that make the study treatment unsafe, such as:
- Lung disease or history of lung inflammation.
- Active infections requiring treatment.
- Significant heart disease or recent heart attack.
- History of organ transplant.
- Require high doses of steroids or other immune-suppressing medications.
- Have active autoimmune diseases requiring treatment in the past two years, except for certain conditions like stable hypothyroidism.
- Have allergies to any components of the study drugs.
- Have had another active cancer in the past two years, except for certain skin cancers or other localized cancers that have been treated.
- Have HIV with a detectable viral load, unless on effective treatment.
- Have active hepatitis B or C infections, unless on effective treatment with undetectable viral load.
- Have received a live vaccine within 30 days before starting the study treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | 11553 | Uniondale | New York |
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