IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • IBI343,sintilimab,oxaliplatin,S-1
  • sintilimab,oxaliplatin,S-1

Treatment groups

90 Participants
are divided into 2 treatment groups