XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma
Trial Parameters
Brief 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.
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). * Estimated lifetime is greater than 6 months. * The main organs are functioning well, and the blood test results within 14 days before enrollment should meet the following requirements: 1. Routine blood test: 1. Hemoglobin (HB) ≥90 g/L. 2. Neutrophil count (ANC) ≥1.5×109/L. 3. Platelet count (PLT) ≥100×109/L. 2. Biochemical test: 1. Total bilirubin≤1.5×ULN (upper limit of normal). 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT and AST ≤ 5×ULN. 3. Serum creatinine (Cr) ≤1.5 ULN or creatinine clearance ≥60mL/min. * No obvious clinical symptoms of heart disease. * Must have disease-free status documented by complete physical examinat