To introduce clinical trial protocols for traditional Chinese medicine therapy in gastric cancer with hypercoagulable state and to evaluate the design features of this protocol. Methods:The advanced gastric cancer patients with hypercoagulable state were taken as subjects in multi-centered, prospective, pragmatic randomly controlled trial conducted in accordance with the guidelines of Good Clinical Practice (GCP). Relevant indexes and indicators were analyzed to objectively evaluate the efficacy of traditional Chinese medicine therapy for gastric cancer complicated with hypercoagulable state and to explore its clinical mechanism according to the tonifying qi and activating blood circulation theory. Results:Combined with modern laboratory indicators, the theory of “qi deficiency and blood stasis” was applied to determine the clinical efficacy and effect mechanism of traditional Chinese medicine therapy for patients with gastric cancer with hypercoagulable state. Conclusion:This clinical trial protocol for traditional Chinese medicine therapy in treating gastric cancer complicated with hypercoagulable state is scientific and applicable by integrating clinical symptoms and objective laboratory indicators under the guidance of Chinese medicine theory and it lays a foundation for future clinical application and professional acknowledgement.