Stomach Neoplasm Clinical Trial
Official title:
Cytoreductive Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy and Systemic Chemotherapy in Gastric Cancer With Regional Peritoneal Metastasis, a Multicenter and Single-arm Phase III Study
This study evaluates the survival benefit and safety of cytoreductive surgery(CRS) combined with HIPEC and chemotherapy in gastric cancer with peritoneal metastasis.
Peritoneal metastasis is one of the most frequent non-curable factors in advanced gastric
cancer with poor prognosis, the median survival time of patients is less than 1 year and even
worse in China. Recently, several new modalities have been developed and reported to improve
survival, including the new chemotherapeutic agents, molecular targeting agents and
hyperthermic intraperitoneal chemotherapy（HIPEC）.Still, the long-term outcomes based on
multicenter randomized clinical trials (RCTs) are awaited.
The surgical approach to metastatic lesions has been proved to play a very crucial role in
prolonging the survival of metastatic colorectal patients, which might be able to cure
patients with the operation aiming at R0 resection. For patients with metastatic gastric
cancer, surgical intervention of primary tumor and measurable metastatic lesion is
technically feasible, while the survival benefit is controversial. Even though the REGATTA
trial demonstrated that the removal of the primary tumor is not necessarily beneficial, the
role of operation aiming at R0 resection combined with new regimens like HIPEC and new
chemotherapeutic agents is still confusing and new categories of classification for
metastatic gastric cancer based on the treatment response is needed.
In order to evaluate the survival benefit and safety of cytoreductive surgery(CRS) and HIPEC
before beginning chemotherapy in gastric cancer with peritoneal metastasis, patients who
fulfill the inclusion and exclusion criteria will be recruited in this study and receive CRS,
HIPEC and chemotherapy. Chemotherapy regimen based on cisplatin and fluorouracil(CF) are
recommended. Patients are followed up for 2 years and the safety and survival outcome will be
analyzed.
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