Gastric cancer with bone marrow metastasis and disseminated intravascular coagulation constitutes a highly aggressive gastric cancer subtype which presents a peculiar biological behavior and very poor prognosis. Retrospective studies have shown chemotherapy could prolong survival, but a prospective trial is still unavailable. This study is the first prospective clinical trial to evaluate the safety and efficacy of chemotherapy for advanced gastric cancer patients with bone marrow metastasis.
Trial registration: ClinicalTrials.gov NCT04547153.
Highly aggressive gastric cancer is a special subtype gastric cancer with highly aggressive biological behavior and very poor prognosis. This is a multicenter phase II clinical trial. Infusional fluorouracil of 200 mg/m2 on days 1–21 with docetaxel 25 mg/m2 on days 1, 8 and 15 will be administered as the first-line therapy to highly aggressive gastric cancer with platelet lower than 50 × 109/l, every 4 weeks. The primary end point is the hematological response rate, which is defined as the percentage of participants whose platelet count restores to normal range. The secondary end points are time to hematological response, 1-month mortality, overall survival, toxicity and quality of life. This study will provide high-level evidence to guide clinical practice for highly aggressive gastric cancer. Clinical Trial Registration: NCT04547153 (ClinicalTrials.gov).