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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

NCT07643623 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2026-08-14

No results posted yet for this 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.

Conditions

  • Resectable Gastric/Gastroesophageal Junction Adenocarcinoma

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

Sponsors & Collaborators

  • Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2031-12-31
Completion
2031-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07643623 on ClinicalTrials.gov