XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma

Recruiting Phase 2 Interventional Study
Carcinoma Gastrointestinal Diseases Stomach Cancer Gastroesophageal-junction Cancer Digestive System Diseases Gastric Cancer Gastrointestinal Neoplasms
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 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
The First Affiliated Hospital with Nanjing Medical University · Other
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About This Trial
This is an open label, randomized, phase Ⅱ, multi-cohort study to treat subjects with ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma. The patients will be randomized into two arms consist of Penpulimab + Anlotinib (3 weeks/cycle) + XELOX and XELOX at a ratio of 1:1. This study is conducted to assess safety and anti-tumor activity of the monoclonal antibody Penpulimab in combina…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Subjects aged ≥18 and ≤75 years old, male or female. * ECOG performance status score 0-1. * Histologically or cytologically confirmed GC or GEJ carcinoma, had been treated with Radical resection (D2, R0 or R1) of gastric cancer. * Pathological stage:III (8th AJCC TNM). * Estim…
Contacts

Yongqian Shu, PhD

0086-025-68306428

shuyongqian@csco.org.cn

CONTACT

Xiaofeng Chen, PhD

0086-13585172006

xiaofengch198019@126.com

CONTACT