XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma, a Randomized, Controlled, Multicenter Clinical Trial (EXPLORING)

NCT05494060 Phase 2 RECRUITING

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.

Details

Lead sponsor	The First Affiliated Hospital with Nanjing Medical University
Phase	Phase 2
Status	RECRUITING
Enrolment	80
Start date	2022-03-16
Completion	2027-02

Conditions

• Carcinoma
• Gastrointestinal Diseases
• Stomach Cancer
• Gastroesophageal-junction Cancer
• Digestive System Diseases
• Gastric Cancer
• Gastrointestinal Neoplasms

Interventions

• Anlotinib hydrochloride capsule
• Penpulimab Injection
• XELOX

Primary outcomes

• Disease Free Survival (DFS) — up to 2 years
  From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence).

Countries

China