This is a Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined with Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
720
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
The MPR rate is defined as the proportion of participants with a Tumor Regression Grade (TRG) score of 0 or 1 in the primary tumor after radical surgical resection following neoadjuvant therapy.
Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Event-Free Survival (EFS)
The EFS is defined as the time from randomization to the first occurrence of disease progression precluding curative resection, postoperative local recurrence, distant metastasis, or death from any cause.
Time frame: Up to approximately 5 years
pathological Complete Response (pCR) rate
The pCR rate is defined as the proportion of participants with no residual viable tumor in both the primary tumor and lymph nodes after radical surgical resection following neoadjuvant therapy.
Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Clinical Down-staging Rate
Clinical downstaging rate refers to the proportion of participants with a reduction in clinical TNM (cTNM) stage after neoadjuvant therapy.
Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
R0 resection rate
The R0 resection rate is defined as the proportion of participants who underwent R0 resection.
Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Overall survival (OS)
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1mg/kg, D1 IV Q6W
130 mg/m2 D1 IV Q3W
1mg/kg, D1 IV Q6W
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 5 years
numbers of subjects with adverse events
defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Time frame: Up to approximately 5 years
numbers of subjects with serious adverse events
Defined as any serious untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Time frame: Up to approximately 5 years