First-line therapy for gastric cancer with bone marrow metastasis and disseminated intravascular coagulation with infusional fluorouracil and weekly docetaxel: A multicenter, phase II clinical trail.

e16004 Background: Gastric cancer (GC) with bone marrow metastasis (BMM) and disseminated intravascular coagulation (DIC) is a special subtype of gastric cancer which has highly aggressive characteristic and extremely poor prognosis. Case reports showed chemotherapy achieved survival benefit but prospective trial is still urgently needed. Methods: This is a multi-center phase II clinical trial. Infusional fluorouracil of 200mg/m2/day, D1-21 (LD-FU) with docetaxel 25mg/m2, D1,D8,D15 will be administered to chemo-naïve metastatic GC with BMM and DIC every four weeks. The primary endpoint is the hematology response rate (HeRR) defined as the rate of platelet count restored to 100X109/L or higher. The secondary endpoints are time to HeR, duration of HeR, one-month mortality, overall survival, toxicity and the quality of life. Results: Until Feb 1, 2022, 11 gastric cancer patients with BM and DIC were enrolled in this trail and 8 patients reached the hematology response. The HeRR is 72.72%(8/11) and the media time to HeR is 13.5 days (11-20days). The rate of grade 1or to oral mucositis is 36.36%(4/11) and there is no grade 3 or 4 treatment toxicity. Conclusions: This is the first prospective clinical trail to evaluate the safety and efficacy of chemotherapy for advanced GC patients with BMM and DIC and will provide high level evidence to guide clinical practice. Clinical trial information: NCT04547153.