XiangShaLiuJunZi Decoction combined with S-1 in the maintenance treatment of Stage III and IV Gastric Cancer: a protocol for a randomized controlled trial

Background The total effective rate of first-line chemotherapy based on fluorouracils and platinum for advanced gastric cancer is about 31%-64%, but most of Patients will develop worse after 3-8 months, while second-line chemotherapy is seems inefficient and prone to serious adverse chemotherapy reactions. The new oral fluorouracil chemotherapeutic drug, S-1, has been increasingly used in clinical maintenance after first-line chemotherapy for stage III and IV gastric cancer because of its its own advantages. In addition, the effects of XiangshaLiujunzi Decoction(XSLJZD) and other traditional Chinese medicines(TCM) on alleviating the side effects of chemotherapy and improving the quality of life of cancer patients have been gradually confirmed, no more reports about the maintenance treatment mode of combination of western medicine and TCM. We designed the trial of XSLJZD combined with S-1 in the maintenance treatment of Stage III and IV Gastric Cancer, hoped that this research program will go further and comprehensively evaluate its effectiveness, safety and superiority.Methods/design This trial is an open, Single-center, randomized trial. Patients with stage III and stage IV gastric cancer will be randomized into group A (S-1), group B (S-1 combined with XSLJZD), and group C (symptomatic treatment/observation) for five year of corresponding treatment. Accordingly, the primary endpoint of this trial was progression-free survival (PFS), along with the secondary end point was Overall survival(OS) and Quality of Life Assessment (QOLA), the latter includes improvement in symptoms before and after treatment, Karnofsky Performance Status (KPS), and adverse events (AEs) assessment.Discussion The results of this trial can uncover to some extent that S-1 or S-1 combined with XSLJZD on PFS, OS and QOLA in the maintenance period of stage III and IV gastric cancer, as well as provide a preliminary basis for the effectiveness of S-1 combined with XSLJZD in the maintenance period of stage III and IV gastric cancer.