Phase
Condition
Stomach Cancer
Gastric Cancer
Digestive System Neoplasms
Treatment
Proximal radical gastrectomy
Total radical gastrectomy
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- To be eligible to participate in this study, all patients must meet all thefollowing criteria:
The subjects voluntarily joined the study and were able to sign the informedconsent with good compliance;
Age 18-75 years old (at the time of signing the informed consent), both maleand female;
Histologically and/or cytologically confirmed upper gastric carcinoma (adenocarcinoma), locally advanced according to AJCC Edition 8 criteria, cT3-4or N+M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with diagnostic laparoscopic exploration if necessary) , and consentto neoadjuvant therapy. Investigators assessed the lesion as resectable orpotentially resectable;
Have not received systematic treatment for the current disease, includinganti-tumor chemoradiotherapy/immunotherapy;
ECOG score 0-1;
Expected survival ≥6 months;
Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distantmetastasis;
The major organs function well and meet the following criteria:
Blood routine examination (no blood transfusion within 14 days, nohematopoietic stimulating drugs to correct the state) : hemoglobin (Hb) ≥90g/L;Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet (PLT) ≥80×109/L;
Biochemical examination: alanine aminotransferase (ALT) and aspartateaminotransferase (AST) ≤2.5×ULN; Serum total bilirubin (TBIL) ≤1.5×ULN; Serumcreatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥60mL/min;
Coagulation function: activated partial thromboplastin time (APTT),International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;
Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%;
Assessed with adequate organ function by doctors. 9. Fertile subjects must useappropriate methods of contraception during the study period and within 120days after the end of the study, have a negative serological pregnancy testwithin 7 days prior to study enrollment, and must be non-lactating subjects.
Exclusion
Exclusion Criteria:
- To be eligible to participate in this study, all patients must meet all thefollowing criteria:
The subjects voluntarily joined the study and were able to sign the informedconsent with good compliance;
Age 18-75 years old (at the time of signing the informed consent), both maleand female;
Histologically and/or cytologically confirmed upper gastric carcinoma (adenocarcinoma), locally advanced according to AJCC Edition 8 criteria, cT3-4or N+M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with diagnostic laparoscopic exploration if necessary) , and consentto neoadjuvant therapy. Investigators assessed the lesion as resectable orpotentially resectable;
Have not received systematic treatment for the current disease, includinganti-tumor chemoradiotherapy/immunotherapy;
ECOG score 0-1;
Expected survival ≥6 months;
Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distantmetastasis;
The major organs function well and meet the following criteria:
Blood routine examination (no blood transfusion within 14 days, nohematopoietic stimulating drugs to correct the state) : hemoglobin (Hb) ≥90g/L;Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet (PLT) ≥80×109/L;
Biochemical examination: alanine aminotransferase (ALT) and aspartateaminotransferase (AST) ≤2.5×ULN; Serum total bilirubin (TBIL) ≤1.5×ULN; Serumcreatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥60mL/min;
Coagulation function: activated partial thromboplastin time (APTT),International standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;
Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥50%;
Assessed with adequate organ function by doctors. 9. Fertile subjects must useappropriate methods of contraception during the study period and within 120days after the end of the study, have a negative serological pregnancy testwithin 7 days prior to study enrollment, and must be non-lactating subjects.
Study Design
Study Description
Connect with a study center
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei 430030
ChinaActive - Recruiting

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