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NOT YET RECRUITING
NCT07643623
PHASE2/PHASE3

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.

View on ClinicalTrials.gov

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

DRUG

tegafur, Gimeracil and Oteracil Potassium Capsules

40mg/m2, D1-14 BID PO Q3W

DRUG

Sintilimab Placebo

200 mg, D1 IV Q3W

DRUG

Sintilimab

200mg D1 IV Q3W

DRUG

Ipilimumab N01

1mg/kg, D1 IV Q6W

DRUG

Oxaliplatin for injection

130 mg/m2 D1 IV Q3W

DRUG

Ipilimumab N01 Placebo

1mg/kg, D1 IV Q6W

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China