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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Drug: tegafur, Gimeracil and Oteracil Potassium Capsules; Drug: Sintilimab; Drug: Oxaliplatin for injection; Drug: Ipilimumab N01 Placebo; Drug: Ipilimumab N01; Drug: Sintilimab Placebo

• Study Type: Interventional
• Enrollment (Estimated): 720
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Chunxian Hu; Phone Number: +86 021 3183 7200; Email: chunxian.hu@innoventbio.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun yat-sen University Cancer Center
      • Contact: Ruihua Xu; Phone Number: 020-87343468; Email: xurh@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sintilimab; Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.	Drug: tegafur, Gimeracil and Oteracil Potassium Capsules; 40mg/m2, D1-14 BID PO Q3W; Drug: Sintilimab; 200mg D1 IV Q3W; Drug: Oxaliplatin for injection; 130 mg/m2 D1 IV Q3W; Drug: Ipilimumab N01 Placebo; 1mg/kg, D1 IV Q6W
Experimental: Sintilimab+Ipilimumab N01; Neoadjuvant Treatment period: up to 3 cycles of sintilimab plus chemotherapy in combination with Ipilimumab N01 prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab plus chemotherapy, and then receive sintilimab therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.	Drug: tegafur, Gimeracil and Oteracil Potassium Capsules; 40mg/m2, D1-14 BID PO Q3W; Drug: Sintilimab; 200mg D1 IV Q3W; Drug: Oxaliplatin for injection; 130 mg/m2 D1 IV Q3W; Drug: Ipilimumab N01; 1mg/kg, D1 IV Q6W
Active Comparator: Sintilimab placebo+Ipilimumab N01 placebo; Neoadjuvant Treatment period: up to 3 cycles of sintilimab placebo plus chemotherapy in combination with Ipilimumab N01 Placebo prior to surgery. adjuvant Treatment period: Subjects will receive 5 cycles of sintilimab placebo plus chemotherapy, and then receive sintilimab placebo therapy after surgery until disease recurrence, unacceptable toxicity, receiving new anti-tumor therapy, withdrawal of informed consent (ICF), lost to follow-up or death, or other conditions that require treatment discontinuation (whichever occurs first). The maximum duration of postoperative treatment with either sintilimab or placebo is 13 cycles.	Drug: tegafur, Gimeracil and Oteracil Potassium Capsules; 40mg/m2, D1-14 BID PO Q3W; Drug: Oxaliplatin for injection; 130 mg/m2 D1 IV Q3W; Drug: Ipilimumab N01 Placebo; 1mg/kg, D1 IV Q6W; Drug: Sintilimab Placebo; 200 mg, D1 IV Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma	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.	Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Event-Free Survival (EFS)	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.	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to approximately 5 years
pathological Complete Response (pCR) rate	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.	Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
Clinical Down-staging Rate	Clinical downstaging rate refers to the proportion of participants with a reduction in clinical TNM (cTNM) stage after neoadjuvant therapy.	Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
R0 resection rate	The R0 resection rate is defined as the proportion of participants who underwent R0 resection.	Up to approximately 6 weeks following the beginning of Post-operative Assessment baseline(up to Study 2 years )
numbers of subjects with adverse events	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	Up to approximately 5 years
numbers of subjects with serious adverse events	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	Up to approximately 5 years

Collaborators and Investigators

• Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Drug Administration Routes; Drug Therapy; Coordination Complexes; Pyrimidines; Uracil; Pyrimidinones; Fluorouracil; Oxaliplatin; Tegafur; Injections; sintilimab; gimeracil; potassium oxonate
• Other Study ID Numbers: CIBI310M301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No