Neoadjuvant and Adjuvant Therapy Studies of Sintilimab Combined With Chemotherapy With or Without Ipilimumab N01 in Resectable Gastric/Gastroesophageal Junction Adenocarcinoma
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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.
View NCT07643623 on ClinicalTrials.gov ↗ ← All trials in China