NCT04483076 Oxaliplatin Combined With S-1(SOX) Neoadjuvant Chemotherapy for Different Cycles in Patients With Gastric Cancer
| NCT ID | NCT04483076 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Chinese PLA General Hospital |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 524 participants |
| Start Date | 2021-01-13 |
| Primary Completion | 2022-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 524 participants in total. It began in 2021-01-13 with a primary completion date of 2022-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
RESONANCE-II trial is a prospective, multicenter, randomized, controlled phase III study which will enroll 524 patients in total. Patients with eligibility will be registered, pre-enrolled and receive three cycles of SOX. Then, tumor response evaluation will be carried out. Those who achieve stable disease or progressive disease will be excluded. Patients achieving complete response or partial response will be enrolled and assigned into either group A for another three cycles of SOX (six cycles in total) followed by D2 surgery and group B for D2 surgery (three cycles in total). The primary endpoint is the rate of pathological complete response and the secondary endpoints are R0 resection rate, three-year disease-free survival, five-year overall survival and safety.
Eligibility Criteria
Inclusion Criteria: 1. Non-bedridden, aged 18 to 70 years old; 2. Eastern Cooperative Oncology Group (ECOG) score is 0 to 1; 3. Histologically confirmed gastric adenocarcinoma; 4. Stage III (American Joint Committee on Cancer (AJCC) TNM staging system 8th edition) gastric cancer confirmed by enhanced computer tomography (enhanced CT) and laparoscopic exploration (endoscopic ultrasonography (EUS) and magnetic resonance imaging (MRI) if necessary); 5. The research center and the surgeon have the ability to complete standard D2 radical gastrectomy, and the gastrectomy can be tolerated by the patient; 6. Laboratory test criteria: peripheral blood hemoglobin (Hb) ≥ 90 g/L, neutrophil absolute 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; 7. Patients with heart disease, the echocardiogram showed that the left ventricular ejection fraction ≥ 50%, the electrocardiogram (ECG) is basically normal within 4 weeks before operation and without no obvious symptoms are acceptable; 8. There is no serious underlying disease that could lead to an expected life expectancy \< 5 years; 9. Willing to sign the inform consent for participation and publication of results. Exclusion Criteria: 1. Pregnant or lactating women; 2. Positive pregnancy test for women in childbearing age. Menopausal women without menstruation for at least 12 months can be regarded as women with no possibility of getting pregnant; 3. Refuse to birth control during the study; 4. Received any chemotherapy, radiotherapy or immunotherapy before; 5. History of other malignant diseases in the last five years (except for cervical carcinoma in situ); 6. History of uncontrolled central nervous system diseases, which could influence the compliance; 7. History of severe liver diseases, renal diseases or respiratory diseases; Uncontrolled diabetes and hypertension; Clinically severe heart disease, such as congestive heart failure, symptomatic coronary heart disease, uncontrolled arrhythmia, or a history of myocardial infarction in the last six months; 8. History of dysphagia, complete or partial gastrointestinal obstruction, active gastrointestinal bleeding and gastrointestinal perforation; 9. On steroid treatment after organ transplant; 10. With uncontrolled severe infections; 11. Known dihydropyrimidine dehydrogenase deficiency (DPD); 12. Anaphylaxis to any research drug ingredient; 13. Known peripheral neuropathy (\> NCI-CTC AE 1). Patients with only disappearance of deep tendon reflex need not to be excluded.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04483076 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04483076 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 524 participants.
Is NCT04483076 currently recruiting?
Yes, NCT04483076 is actively recruiting participants. Contact the research team at 301wxx@sina.com for enrollment information.
Where is the NCT04483076 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04483076 clinical trial?
NCT04483076 is sponsored by Chinese PLA General Hospital. The trial plans to enroll 524 participants.
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