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NCT Number: NCT07643623

Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma

This is a Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined with Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma.

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Key information

Conditions

Resectable Gastric/Gastroesophageal Junction Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed written Informed Consent Form (ICF) and ability to comply with protocol-specified visits and related procedures.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Expected survival ≥ 6 months.
  • 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.
  • 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.
  • 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

  • Histologically or cytologically confirmed other pathologic types (e.g., squamous cell carcinoma, sarcoma, undifferentiated carcinoma) or combined gastrointestinal stromal tumor (GIST) before randomization.
  • Suspicious metastatic lesions or locally advanced unresectable disease, regardless of stage.
  • 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.
  • Active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
  • Inability to swallow, malabsorption syndrome, or uncontrolled nausea/vomiting/diarrhea, or other severe gastrointestinal diseases affecting drug intake/absorption.
  • Any life-threatening bleeding event within 3 months before randomization, or grade 3/4 gastrointestinal/variceal bleeding requiring endoscopic/surgical intervention.
  • Active uncontrolled bleeding or known bleeding diathesis.

Treatment and study plan

tegafur, Gimeracil and Oteracil Potassium Capsules

Drug

40mg/m2, D1-14 BID PO Q3W

Sintilimab Placebo

Drug

200 mg, D1 IV Q3W

Sintilimab

Drug

200mg D1 IV Q3W

Ipilimumab N01

Drug

1mg/kg, D1 IV Q6W

Oxaliplatin for injection

Drug

130 mg/m2 D1 IV Q3W

Ipilimumab N01 Placebo

Drug

1mg/kg, D1 IV Q6W

Primary outcomes

  1. Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma

    Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )

    The MPR rate is defined as the proportion of participants with a Tumor Regression Grade (TRG) score of 0 or 1 in the primary tumor after radical surgical resection following neoadjuvant therapy.

  2. Event-Free Survival (EFS)

    Time frame: Up to approximately 5 years

    The EFS is defined as the time from randomization to the first occurrence of disease progression precluding curative resection, postoperative local recurrence, distant metastasis, or death from any cause.

Secondary outcomes

  1. pathological Complete Response (pCR) rate

    Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )

    The pCR rate is defined as the proportion of participants with no residual viable tumor in both the primary tumor and lymph nodes after radical surgical resection following neoadjuvant therapy.

  2. Clinical Down-staging Rate

    Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )

    Clinical downstaging rate refers to the proportion of participants with a reduction in clinical TNM (cTNM) stage after neoadjuvant therapy.

  3. R0 resection rate

    Time frame: Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )

    The R0 resection rate is defined as the proportion of participants who underwent R0 resection.

  4. Overall survival (OS)

    Time frame: Up to approximately 5 years

    OS is defined as the time from randomization to death due to any cause.

  5. numbers of subjects with adverse events

    Time frame: Up to approximately 5 years

    defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed

  6. numbers of subjects with serious adverse events

    Time frame: Up to approximately 5 years

    Defined as any serious untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed

Study contacts

Contact information is provided by the study sponsor or research team.

Chunxian Hu

CONTACT

[email protected]

+86 021 3183 7200

Sponsors and collaborators

Lead sponsor

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Phase II/III Clinical Study of the Efficacy and Safety of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction Adenocarcinoma

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.