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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT07483567
Phase
PHASE2
Status
Recruiting
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Conditions

  • CLDN18.2 Positive
  • Gastroesophageal Junction Adenocarcinoma
  • Primary Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 19, 2026
Start date
Apr 17, 2026
Status verified
May 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2031

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: experimental group
  • Active Comparator: control group

Primary Outcome Measure

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 ]

Central Contacts

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