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Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
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.
Official 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
720
Start Date
2026-06-15
Completion Date
2031-12-31
Last Updated
2026-06-11
Healthy Volunteers
No
Interventions
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
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China