drugset / Trial / NCT05494060

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

NCT05494060

RandomizedParallel-groupOpen-labelTreatment

Summary

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 combination with Anlotinib and standard chemotherapy as adjuvant treatment for ctDNA-positive Gastric, or Gastroesophageal Junction Carcinoma.

Timeline

Start
2022-03-16
Primary completion
2024-12
Completion
2027-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2
Subject Catequentinib Small molecule 12 mg Oral
Subject Oxaliplatin Small molecule 130 mg/m2
Subject Penpulimab Monoclonal antibody 200 mg Intravenous