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.
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).
Participation in other drug clinical trials within four weeks.
Multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction.
History of bleeding, any bleeding event with a severity grade of 3 or higher per CTCAE 5.0 within 4 weeks before screening.
Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastases, CT or MRI must be performed within 28 days before enrollment to rule out central nervous system metastases.
Parallel
Anlotinib hydrochloride capsule
DrugAnlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)；
Penpulimab Injection
DrugPenpulimab Injection 100mg per bottle, 200mg IV Day 1, cycled every 21 days
XELOX
DrugCapecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w
Disease Free Survival (DFS)
From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence).
Disease Free Survival (DFS) rate at 2 years
From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), assessed at 2 years.
Disease Free Survival (DFS) rate at 3 years
From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), assessed at 3 years.
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Toxicity by CTCAE v5.0 criteria
oxicity and safety analysis will occur in patients who received at least one full or partial dose of study treatment. Adverse events will be graded per NCI CTCAE v.5.0.
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The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborator
