Sintilimab with chemotherapy, with or without ipilimumab, for resectable stomach/GEJ cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial compares perioperative treatment regimens that include sintilimab plus chemotherapy, with or without ipilimumab, in patients with resectable gastric or GEJ adenocarcinoma. It is a randomized, double-blind, phase II/III study designed to assess safety and efficacy of the regimens in contexts around surgical resection. Eligible participants are adults with confirmed stage II–IVa gastric/GEJ cancer, fit for radical resection, and appropriate performance status. Interventions include tegafur/gimeracil/oteracil potassium, chemotherapy, sintilimab (with or without ipilimumab), as well as placebo controls for blinding. Primary endpoints typically include pathologic response and event-free survival, with safety monitored throughout the perioperative period.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Signed written Informed Consent Form (ICF) and ability to comply with protocol-specified visits and related procedures.
2. Age ≥ 18 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
4. Expected survival ≥ 6 months.
5. Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ). For GEJ cancer, only Siewert type III and Siewert type II participants not requiring combined thoracotomy are eligible.
6. Clinical stage T3-4Nany or TanyN+M0 (stage II-IVa) gastric/GEJ adenocarcinoma confirmed by endoscopic ultrasound or contrast-enhanced CT/MRI within 4 weeks before the first dose, per the American Joint Committee on Cancer (AJCC) 8th edition gastric cancer TNM staging system.
7. Within 4 weeks before the first dose, evaluated by a responsible surgeon based on medical history and confirmed to meet study requirements for radical R0 resection.

Exclusion Criteria

1. Histologically or cytologically confirmed other pathologic types (e.g., squamous cell carcinoma, sarcoma, undifferentiated carcinoma) or combined gastrointestinal stromal tumor (GIST) before randomization.
2. Suspicious metastatic lesions or locally advanced unresectable disease, regardless of stage.
3. History of gastrointestinal perforation or fistula within 6 months before randomization. May be enrolled if perforation/fistula has been surgically treated (repaired/resected) and disease recovery/remission is confirmed by the investigator.
4. Active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
5. Inability to swallow, malabsorption syndrome, or uncontrolled nausea/vomiting/diarrhea, or other severe gastrointestinal diseases affecting drug intake/absorption.
6. Any life-threatening bleeding event within 3 months before randomization, or grade 3/4 gastrointestinal/variceal bleeding requiring endoscopic/surgical intervention.
7. Active uncontrolled bleeding or known bleeding diathesis.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Chunxian Hu
• Email: chunxian.hu@innoventbio.com
• Phone: +86 021 3183 7200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.