drugset / Trial / NCT05494060
XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma
Phase 2
Recruiting
80 enrolled
The First Affiliated Hospital with Nanjing Medical University
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |