This study investigates treatment of cadonilimab or placebo combined with SOX chemotherapy (oxaliplatin + tegafur-gimeracil-oteracil potassium) given before surgery (neoadjuvant) and cadonilimab or placebo combined with SOX chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer.
This trial is a Phase 3 study. All patients are resectable gastric or gastroesophageal junction adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy for perioperative treatment of resectable gastric or gastroesophageal junction adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
760
Anti-PD-1/ CTLA-4 tetrameric bispecific antibody
A combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium
Placebo
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGFujian Provincial Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGFourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Event-free survival (EFS)
EFS is the time from date of randomization until the date of disease progression or death.
Time frame: Up to 5 years
Pathological Complete Response (pathCR) Rate
PathCR rate is defined as the percentage of participants having a pathCR assessed by the investigators. PathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes.
Time frame: Up to approximately 2 years
Overall survival (OS)
Overall survival is length of time from randomization until the date of death due to any cause.
Time frame: Up to 10 years
Disease-free Survival (DFS)
DFS is defined as the time from post-surgery baseline scan until the first occurrence of local or distant recurrence or death from any cause.
Time frame: Up to 5 years
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGZhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGTianjin Provincial Tumor Hospital
Tianjin, Tianjin Municipality, China
RECRUITING