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.
Signed written informed consent and able to comply with the visit and related procedures as specified in the protocol.
Male or female, 18 years ≤ age ≤ 75 years;
ECOG score 0-1;
Histologically confirmed, previously untreated patients with gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction; only Siewert II/III type participants are allowed for gastroesophageal junction cancer;
HER2 positive.
Currently participating in another interventional clinical study, except for those in the follow-up phase of an interventional study.
Previous use of traditional Chinese medicine, Chinese patent medicines, or immunomodulators must be ≥2 weeks before starting the study medication.
Received treatment with a strong CYP3A4 inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug.
Parallel
IBI343,sintilimab,oxaliplatin,S-1
DrugIBI343,sintilimab,oxaliplatin,S-1
sintilimab,oxaliplatin,S-1
Drugsintilimab,oxaliplatin,S-1
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.
Dose-limiting toxicity (DLT), to determine MTD and/or RP2D
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.
Major pathologic response rate (MPR)：The proportion of participants with postoperative pathology showing residual tumor cells ≤10%.
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.
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.
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