A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric/Gastroesophageal Junction Adenocarcinoma

Recruiting Phase 2 Interventional Study
Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
276 (estimated)
Sponsor
Fudan University · Other
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About This Trial
This study aims to explore the efficacy and safety of sintilimab combined with SOX versus SOX alone as adjuvant therapy for patients with pIIIC stage or dMMR/MSI-H pIIIA/IIIB stage gastric/gastroesophageal junction adenocarcinoma. A total of 276 subjects are planned to be enrolled in this study. Patients will be randomly assigned in a 1:1 ratio to receive up to 8 cycles of sintilimab combined with…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Signed written informed consent. 2. Male or female, age ≥18 years. 3. Histopathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ). 4. Diagnosed with pTNM stage IIIC or pTNM stage IIIA/IIIB. 5. Diagnosed with mismatch repair deficiency (dMMR)…
Contacts

Xiaowen Liu

18017317145

liuxw1129@hotmail.com

CONTACT