The core of this study lies in directly addressing the most pressing clinical uncertainty in the current field: For patients with advanced metastatic gastric cancer who have achieved significant radiological remission after conversion therapy, should the addition of radical surgical intervention on top of the best medical treatment bring clear survival benefits to these patients? Answering this question is of extreme importance and urgency, directly affecting the treatment decisions, quality of life, and survival outcomes of a large number of patients.
The innovation and scientific nature of this study lie in its adoption of a multi-center, randomized controlled Phase II study design for the first time. It directly compares the efficacy differences between "surgery + postoperative adjuvant therapy" and "simple continuation of medical treatment" for this specific population, aiming to eliminate selection bias and confirm the causal relationship. We strictly limited the enrolled population to those with "significant imaging remission and technically resectable at R0 level" by MDT assessment, ensuring the homogeneity of the research subjects and the specificity of the questions. The primary research endpoint was set as progression-free survival (PFS), and secondary endpoints included overall survival (OS), R0 resection rate, quality of life (QoL), and treatment-related toxic side effects, allowing for a comprehensive evaluation. Carrying out this study has significant scientific and clinical value. Its results will provide Level 1 evidence-based medical evidence for the treatment strategy of this population. If the surgical group shows superiority, it will firmly establish the position of surgery and promote it to become the standard treatment; if the results are negative (equivalence between the two groups or the surgical group is inferior), it will avoid a large number of patients suffering from unnecessary surgical trauma, promoting the treatment model to return to a core of systematic treatment, thereby changing global clinical guidelines. At the same time, the study has important health economics significance, helping to allocate limited medical resources to truly benefit patients. Through exploratory research on biological specimens, it can also deepen the understanding of the biological behavior of advanced gastric cancer and provide clues for more precise patient screening in the future.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Surgical radical resection (primary lesion + metastatic lesion)
Without surgery, continue with the original medical treatment plan until the disease progresses or intolerable toxicity occurs.
Fudan University Cancer Hospital
Shanghai, China
RECRUITING2-year PFS
Two-year progression-free survival rate
Time frame: 2 year
2-year OS
2 year Overall Survival
Time frame: 2 year
The R0 resection rate
The R0 resection rate of surgery group
Time frame: 2 year
Xu Dazhi Director of Gastric Surgery Department, Doctoral candidate
CONTACT
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