Last updated: January 17, 2021
Sponsor: Chinese PLA General Hospital
Overall Status: Active - Recruiting
Phase
3
Condition
Gastric Cancer
Stomach Cancer
Digestive System Neoplasms
Treatment
N/AClinical Study ID
NCT04483076
RESONANCE-II
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Non-bedridden, aged 18 to 70 years old;
- Eastern Cooperative Oncology Group (ECOG) score is 0 to 1;
- Histologically confirmed gastric adenocarcinoma;
- Stage III (American Joint Committee on Cancer (AJCC) TNM staging system 8th edition)gastric cancer confirmed by enhanced computer tomography (enhanced CT) andlaparoscopic exploration (endoscopic ultrasonography (EUS) and magnetic resonanceimaging (MRI) if necessary);
- The research center and the surgeon have the ability to complete standard D2 radicalgastrectomy, and the gastrectomy can be tolerated by the patient;
- Laboratory test criteria: peripheral blood hemoglobin (Hb) ≥ 90 g/L, neutrophilabsolute count ≥ 3×109 /L, platelet count (PLT) ≥ 100×109 /L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), total bilirubin ≤ 1.5×ULN, serum creatinine (SCr) ≤ 1.5×ULN, and serum albumin (ALB) ≥ 30 g/L;
- Patients with heart disease, the echocardiogram showed that the left ventricularejection fraction ≥ 50%, the electrocardiogram (ECG) is basically normal within 4weeks before operation and without no obvious symptoms are acceptable;
- There is no serious underlying disease that could lead to an expected life expectancy < 5 years;
- Willing to sign the inform consent for participation and publication of results.
Exclusion
Exclusion Criteria:
- Pregnant or lactating women;
- Positive pregnancy test for women in childbearing age. Menopausal women withoutmenstruation for at least 12 months can be regarded as women with no possibility ofgetting pregnant;
- Refuse to birth control during the study;
- Received any chemotherapy, radiotherapy or immunotherapy before;
- History of other malignant diseases in the last five years (except for cervicalcarcinoma in situ);
- History of uncontrolled central nervous system diseases, which could influence thecompliance;
- History of severe liver diseases, renal diseases or respiratory diseases; Uncontrolleddiabetes and hypertension; Clinically severe heart disease, such as congestive heartfailure, symptomatic coronary heart disease, uncontrolled arrhythmia, or a history ofmyocardial infarction in the last six months;
- History of dysphagia, complete or partial gastrointestinal obstruction, activegastrointestinal bleeding and gastrointestinal perforation;
- On steroid treatment after organ transplant;
- With uncontrolled severe infections;
- Known dihydropyrimidine dehydrogenase deficiency (DPD);
- Anaphylaxis to any research drug ingredient;
- Known peripheral neuropathy (> NCI-CTC AE 1). Patients with only disappearance of deeptendon reflex need not to be excluded.
Study Design
Total Participants: 524
Study Start date:
January 13, 2021
Estimated Completion Date:
December 31, 2028
Study Description
Connect with a study center
Chinese PLA General Hospital
Beijing, Beijing 100853
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.