Last updated: January 26, 2022
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Gastric Cancer
Stomach Cancer
Digestive System Neoplasms
Treatment
N/AClinical Study ID
NCT05228743
E20201130
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosed as gastric adenocarcinoma by pathology and had not received any otheranti-tumor treatment such as radiotherapy and chemotherapy;
- ≥ 18 and ≤ 70 years of age; Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1;
- Intraoperative pathological diagnosis was peritoneal metastasis (stage ≤ P1b), with orwithout ascites (ascites volume exceeding pelvic cavity but not reaching fullabdominal ascites)
- Patients have adequate baseline organ and marrow function :hemoglobin≥9g/dL; absoluteneutrophil count (ANC) ≥1,500/mm3; PLT(platelets)≥1000,000/mm3; total bilirubin ≤1.5×upper normal limit(ULN); AST ≤2.5 ×ULN, ALT ≤2.5 ×ULN; prothrombintime-international normalized ratio≤1.5, and APTT(activated partial thromboplastintime) was within normal range; creatine ≤ 1.5 x ULN;
- Written informed consent provided;
Exclusion
Exclusion Criteria:
- Diagnosed as Her-2(+++)/FISH(+) by pathology;
- With other distant metastasis(ovarian metastasis was excluded)
- Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease,respiratory disease or uncontrolled diabetes, hypertension and other chronic systemicdiseases, heart disease with Clinical symptoms, such as congestive heart failure,coronary heart disease symptoms, drug is difficult to control arrhythmia,hypertension, or six months had a myocardial infarction attack, or cardiacinsufficiency;
- Organ transplantation patients need immunosuppressive therapy;
- Severe recurrent infections were not controlled or with other serious concomitantdiseases;
- Patients got other primary malignant tumors (except curable skin basal cell carcinomaand cervical cancer in situ) except gastric cancer within 5 years; Psychiatric diseasewhich require treatment;
- Within 6 months before study starts and in the process of this study, patientsparticipate in other clinical researches;
- Patients with peripheral nervous system disorder or apparent mental disorders or hadthe history of central nervous system disorders;
- Pregnant or lactating women, women of child-bearing potential, unwilling to useadequate contraceptive protection during the process of the study;
- Patients without legal capacity,or medical/ethical reasons may influence the study tocontinue.
Study Design
Total Participants: 180
Study Start date:
September 01, 2020
Estimated Completion Date:
October 31, 2023
Study Description
Connect with a study center
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
Tianjin, Tianjin 300060
ChinaActive - Recruiting
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