Neoadjuvant chemotherapy for gastric cancer using oxaliplatin and S-1

A Prospective, Multicenter, Randomized, Controlled Phase III Study Evaluating Different Cycles of Oxaliplatin Combined With S-1 (SOX) as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: RESONANCE-II Trial

This study is testing if a combination of two drugs, oxaliplatin and S-1, can help people with advanced stomach cancer by shrinking their tumors before surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 524 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT04483076 on ClinicalTrials.gov

What this trial studies

The RESONANCE-II trial is a multicenter, randomized, controlled phase III study aimed at evaluating the efficacy and safety of different cycles of SOX (oxaliplatin combined with S-1) as neoadjuvant chemotherapy for patients with locally advanced gastric cancer. A total of 524 patients will receive three cycles of SOX, followed by tumor response evaluation. Those achieving complete or partial response will be assigned to either continue with three additional cycles of SOX before surgery or proceed directly to surgery after the initial cycles. The primary endpoint is the rate of pathological complete response, with secondary endpoints including resection rates and survival outcomes.

Who should consider this trial

Good fit: Ideal candidates are non-bedridden adults aged 18 to 70 with histologically confirmed stage III gastric adenocarcinoma.

Not a fit: Patients with stable or progressive disease after initial chemotherapy cycles may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve surgical outcomes and survival rates for patients with locally advanced gastric cancer.

How similar studies have performed: Previous studies have shown promising results with neoadjuvant chemotherapy in gastric cancer, suggesting potential for success in this approach.

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.

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xinxin Wang, MD

Conditions Gastric Cancer; Chemotherapy Effect