This study is a prospective, randomized, open, multicenter phase II clinical trial. It plans to enroll 70 participants with locally advanced gastric and gastroesophageal junction adenocarcinoma (G/GEJ AC) who are assessed as suitable for D2 radical surgery and capable of R0 resection.To evaluate the clinical efficacy and tolerability of IBI343 in combination with sintilimab and SOX regimen for perioperative treatment of resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma.Enroll patients who are CLDN18.2 positive.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
IBI343,sintilimab,oxaliplatin,S-1
sintilimab,oxaliplatin,S-1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Pathological complete response rate (pCR rate): defined as the proportion of participants who, after surgery, show complete regression of tumor cells in the primary lesion and lymph node lesions according to pathological examination.
Time frame: Up to 4 years
Dose-limiting toxicity (DLT), to determine MTD and/or RP2D
Time frame: Up to 4 years
Event-free survival (EFS)
Defined as the time from the first dose (randomization) to the first determination of disease progression according to RECIST v1.1, or inability to undergo surgery or need for a change in treatment due to disease progression, local recurrence after surgery or distant metastasis, or death from any cause.
Time frame: Up to 4 years
Major pathologic response rate (MPR):The proportion of participants with postoperative pathology showing residual tumor cells ≤10%.
Time frame: Up to 2 years
Clinical downstaging rate (T and/or N downstaging):The proportion of participants who are ypT0, ypN0, and have a downstaging in preoperative imaging clinical staging compared to baseline imaging clinical staging.
Time frame: Up to 2 years
3-year disease-free survival (3y-DFS):Defined as the time from R0 resection to the first recorded disease recurrence, metastasis, or death from any cause.
Time frame: Up to 2 years
5-year overall survival (5y-OS):Defined as the time from the first dose or randomization date to death from any cause.
Time frame: Up to 2 years
Preoperative objective response rate (ORR) evaluated according to RECIST v1.1.
Time frame: Up to 2 years
Preoperative disease control rate (DCR) evaluated according to RECIST v1.1.
Time frame: Up to 2 years
Adverse Event (AE) incidence and correlation with the investigational drug
Time frame: Up to 2 years
Treatment-Emergent Adverse Event (TEAE) incidence and correlation with the investigational drug.
Time frame: Up to 2 years
Adverse Event of Special Interest (AESI) incidence and correlation with the investigational drug.
Time frame: Up to 2 years
Serious Adverse Event (SAE) incidence and correlation with the investigational drug.
Time frame: Up to 2 years
Incidence of perioperative complications and their correlation with the investigational drug.
Time frame: Up to 2 years
Area under the curve of drug concentration over time for participants treated with IBI343.
Time frame: Up to 2 years
Maximum concentration (Cmax) for participants treated with IBI343.
Time frame: Up to 2 years
Clearance (CL) for participants treated with IBI343.
Time frame: Up to 2 years
Volume of distribution (V) for participants treated with IBI343.
Time frame: Up to 2 years
Half-life for participants treated with IBI343.
Time frame: Up to 2 years
Positive rate of anti-drug antibodies for participants treated with IBI343.
Time frame: Up to 2 years
Positive rate of neutralizing antibodies for participants treated with IBI343.
Time frame: Up to 2 years
The number of participants with abnormal laboratory test results
Time frame: Up to 2 years
the number of participants showing clinically significant findings during physical examination
Time frame: Up to 2 years
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