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A Study of Cadonilimab for Gastric or Gastroesophageal Junction Cancer

This study is looking at whether adding cadonilimab to standard chemotherapy is a safe and effective treatment for people with gastric (stomach) cancer or gastroesophageal junction (GEJ) cancer that is locally advanced or can be removed by surgery. Researchers want to see if this combination improves how long people live without their cancer returning or getting worse. To join, you must be at least 18 years old, have a good general health status, and have gastric or GEJ adenocarcinoma that is resectable (can be surgically removed). The study plans to enroll 37 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 37 participants. It is testing cadonilimab combined with chemotherapy.
What's involved
Participants will receive perioperative cadonilimab plus neoadjuvant chemotherapy, meaning treatment before surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to measure event-free survival (EFS) at 18 months, suggesting follow-up for at least that long.

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NCT07631000

A Study of Cadonilimab Combined With Chemotherapy in People With Gastric or Gastroesophageal Junction Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~37 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:Cadonilimab

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event-free survival (EFS) rata
Measured over 18 months

Conditions

Gastric Cancer
Gastroesophageal-junction Cancer

Explore related trials

Gastric CarcinomaGastroesophageal Junction Adenocarcinoma

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Yelena Janjigian, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Yelena Janjigian, MD
[email protected]
646-888-4286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Capable of providing signed informed consent.
Age ≥18 years at time of informed consent.
ECOG performance status (PS) of 0 or 1 at enrollment.
Pathologically confirmed gastric or GEJ adenocarcinoma with T1 N+ M0 or T2-4 N0-3 M0 (per AJCC 8th edition) resectable disease deemed eligible for radical surgery. A diagnostic laparoscopy is strongly recommended to confirm M0 status.
HER2-negative tumor (IHC 0, 1+, or IHC 2+ and FISH non-amplified).
Adequate organ and marrow function as defined below:

Exclusion

Histologies other than adenocarcinoma, including squamous/adenosquamous cell carcinoma, neuroendocrine, or GI stromal tumor.
HER2-positive tumor (IHC 2+ and FISH-amplified, or IHC 3+).
Prior anticancer treatment for the disease under study (chemotherapy, radiation therapy, chemoradiation, approved or investigational therapy) prior to initiation of study treatment.
Prior receipt of an anti-PD1 or anti-CTLA4 monoclonal antibody, including for prior non-gastric malignancy.
Underlying medical conditions that, in the Investigator's opinion, make the administration of cadonilimab hazardous, including but not limited to:
Concurrent chronic medical condition requiring the use of supraphysiologic doses of corticosteroids (\>10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids not excluded).
Any active autoimmune disease or documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma or atopy.
Known hypersensitivity to any excipient contained in the formulations of study interventions.
Prior active malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer(s), superficial bladder cancer, or carcinoma in-situ of the cervix, breast, or prostate cancer. Other cases of prior malignanices may be allowed after discussion with the Principal Investigator.
Known HIV infection with detectable viral load. Patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
Known acute hepatitis B or chronic hepatitis B infection with active untreated disease. For patients with evidence of chronic infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Known hepatitis C infection with detectable viral RNA. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.
Receipt of a live attenuated vaccine within 30 days of study treatment initiation.

What this trial measures

  • Event-free survival (EFS) rata18 months

    To determine the 18-month event-free survival (EFS) rate in patients with locally advanced, resectable, HER2-negative gastric or GEJ adenocarcinoma treated with perioperative cadonilimab and FLOT chemotherapy