Hepatic metastasis of gastric cancer
Conditions
Interventions
Experimental group:Surgery, radiofrequency combined with chemotherapy
Sponsors
The First Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients who are male or female, aged 20 to 75 years; 2.Patients who were diagnosed histologically with primary gastric adenocarcinoma; 3.Patients diagnosed with clinical T1–3 disease by laparotomy or laparoscopy (for T1-T3 patients with the node positive, in order to eliminate the inter group differences, they were randomly divided into control group or experimental group according to the clinical nodal status (further subgroup: N0–1 vs N2–3). For patients with para-aortic lymph node metastasis above the coeliac axis or below the inferior mesenteric artery (lymph node 16a1/b2 of maximum diameter =1 cm), or both, or T4 patients with the node positive, according to the NCCN diagnosis and treatment guidelines for gastric cancer and the recommendations of our multidisciplinary diagnosis and treatment team, neoadjuvant therapy was first chosen); 4.Patients who will undergo diagnostic laparoscopic exploration combined with peritoneal lavage cytology to exclude peritoneal disseminated implant metastasis that is not visible to the naked eye; 5.Patients who will be examined for the molecular profile of the tumors (HER2, PDL1, MSI and MMR expression) (patients with HER2-positive advanced gastric cancer were excluded since trastuzumab in combination with chemotherapy has become the standard treatment for these patients); 6.Patients with distant metastases that were limited to synchronous liver metastases confirmed by both laparotomy and CT scan; 7.Patients with metastatic liver tumor ranging from 2 to 4 with tumor diameters ranging from 1 cm to 5 cm (In order to avoid the omission of potential liver metastases, we used contrast-enhanced liver ultrasound as one of the means of further screening. Considered that unless data are now available from ongoing trials, ablation for resectable liver metastasis lesions should not be used in radiofrequency of liver resection. We recommend all patients to multidisciplinary tumor boards to determine whether the liver metastasis is actually unresectable.); 8.Patients whose PS (performance status) was from 0 to 1; 9.Patients who have not previously been treated for gastric cancer other than EMR; 10.Patients who have not previously received radiation therapy or chemotherapy for any other malignancy; 11.Patients who have no contraindications to treatment (surgery, radiofrequency ablation, and chemotherapy); 12.Patients and their families voluntarily participated in the study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with a diagnosis of primary tumors other than gastric cancer; 2.Patients who have gastric cancer metastases in sites other than the liver; 3.Patients who have coagulation dysfunction that cannot be corrected; 4.Patients with viral hepatitis and cirrhosis; 5.Patients with diabetes mellitus, uncontrolled or controlled with insulin; 6.Patients treated with systemic steroids; 7.Patients suffering from psychosis; 8.Patients with heart, lung, liver, brain, kidney or other organ failure; 9.Patients who have ascites and cachexia preoperatively, and their general conditions are poor; 10.Patients who refuse to sign the informed consent to take part in this study; 11.Female patients who are during pregnancy or breast-feeding (except for those women who are breast feeding but consenting to surgery and chemotherapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total incidence of complications;PFS; | — |
Countries
China
Contacts
Public ContactJi Gang
The First Affiliated Hospital of Air Force Medical University
Outcome results
None listed