A Study of Cadonilimab Combined With Chemotherapy in People With Gastric or Gastroesophageal Junction Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to find out whether adding cadonilimab to the usual chemotherapy approach is an effective and safe treatment for participants with locally advanced/resectable gastric cancer or gastroesophageal junction (GEJ) cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Cadonilimab
DrugPerioperative cadonilimab plus neoadjuvant chemotherapy
Treatment groups
37 Participants
are divided into 1 treatment groupGroup A: Participants with HER2-negative gastric or GEJ adenocarcinomaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Event-free survival (EFS) rata
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
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov