Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma

Recruiting Phase 3 Interventional Study
Gastric Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. 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 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
540 (estimated)
Sponsor
Sun Yat-sen University · Other
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About This Trial

This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy of modified XELOX plus sintilimab versus standard XELOX plus sintilimab in subjects with advanced HER2-negative gastric or gastroesophageal adenocarcinoma in the first-line treatment. The primary outcome is the progression-free survival (PFS), with a planned enrollment of 540 subjects.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Have a good understanding of the study, are willing to follow the requirements of the study, and voluntarily sign the informed consent form. * Aged ≥ 18 years old and ≤ 75 years old. * Locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma confi…
Contacts

Ruihua Xu, MD

+86 20 87343795

xurh@sysucc.org.cn

CONTACT

Feng Wang, MD, PhD

+86 20 87343795

wangfeng@sysucc.org.cn

CONTACT