drugset / Trial / NCT07643623
Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
Phase 2/3
Not yet recruiting
720 enrolled
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2026-06-15
- Primary completion
- 2031-12-31
- Completion
- 2031-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab N01 | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Background | tegafur, Gimeracil and Oteracil Potassium | Unknown | 40 mg/m2 | Oral |