Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
tegafur, Gimeracil and Oteracil Potassium CapsulesSintilimab PlaceboSintilimabIpilimumab N01Oxaliplatin for injectionIpilimumab N01 Placebo
tegafur, Gimeracil and Oteracil Potassium Capsules: 40mg/m2, D1-14 BID PO Q3W
Sintilimab Placebo: 200 mg, D1 IV Q3W
Sintilimab: 200mg D1 IV Q3W
Ipilimumab N01: 1mg/kg, D1 IV Q6W
Oxaliplatin for injection: 130 mg/m2 D1 IV Q3W
Ipilimumab N01 Placebo: 1mg/kg, D1 IV Q6W
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Major Pathological Response (MPR) rate in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma — 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.
Event-Free Survival (EFS) — 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.
Trial sites (1)
Facility
City
Region
Status
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Recruiting
More Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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