Treatment Strategy for Stage IV Gastric Cancer With Positive Peritoneal Cytology as the Only Non-curable Factor (Cy-plus)
Stomach Neoplasm
About this trial
This is an interventional treatment trial for Stomach Neoplasm focused on measuring gastric cancer, peritoneal cytology
Eligibility Criteria
Inclusion Criteria:
- Pathologically diagnosed gastric adenocarcinoma with endoscopic biopsy;
- Pretreatment clinical stage with computed tomography and/or endoscopic ultrasonography;
- Clinical stage cT2-4 N0-3 M0;
- Standard gastrectomy with D2 lymphadenectomy is needed according to the clinicians' evaluation;
- ECOG performance score ≤2, with tolerance of standard gastrectomy and D2 lymphadenectomy;
- Positive peritoneal cytology;
- Signed informed consent.
Exclusion Criteria:
- Remnant gastric cancer, recurrence gastric cancer or multi-primary cancers;
- Intraoperative identified other unresectable factors including other metastasis except positive peritoneal cytology;
- Postoperative pathologically diagnosed as non adenocarcinoma;
- Pregnant or lactate women;
- Child-bearing period adults who refuse to birth control during the trial;
- Uncontrolled epilepsy, CNS disease or mental disorder that may influence the compliance of the patient;
- Severe/active heart disease, including but not limited to acute coronary syndrome, congestive heart failure with less than NYHA II cardiac function, severe arrhythmia that needs drug control, cardiac infarction within 12 month;
- Organ transplantation patients who needs immune suppression therapy;
- Patients who needs emergency surgery because of bleeding, perforation or obstruction.
Sites / Locations
- Gastrointestinal Cancer Center, Peking University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Chemotherapy-first
Surgery-first
Patients will receive hyperthermic intraperitoneal chemotherapy (HIPEC) during laparoscopic staging. Then 3 cycles of preoperative chemotherapy and clinical evaluation of chemotherapy will be performed. If the patient's disease is evaluated as progressed, the patient will receive systemic therapy. If it's stable or remission, a second time laparoscopic staging and peritoneal cytology examination will be performed. If peritoneal implant is observed, the patients will receive systemic therapy. If the peritoneal cytology is still positive, the treatment will be decided according to the suggestion of MDT discussion. If the peritoneal cytology is converted negative, standard gastrectomy with D2 lymphadenectomy and extensive intraperitoneal lavage (EIPL) will be performed. Postoperative chemotherapy will be determined according to the pathological evaluation of preoperative chemotherapy response.
Patients in this arm will receive standard gastrectomy with D2 lymphadenectomy after randomization. Hyperthermic intraperitoneal chemotherapy (HIPEC) and extensive intraperitoneal lavage (EIPL) will be applied before abdominal closure. After surgery, 8 cycles of postoperative chemotherapy will be performed.