Comparing sequential S-1 therapy after surgery for advanced gastric cancer

Comparison of With and Without Sequential Single Drug Therapy of S-1 After Adjuvant Chemotherapy With Docetaxel Plus S-1 in Stage III Gastric Cancer

This study is testing if a specific treatment plan using S-1 therapy after surgery can help people with advanced stomach cancer recover better.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hanzhou, Zhejiang)
• Trial ID: NCT05813015 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of sequential S-1 adjuvant therapy in patients with locally advanced gastric adenocarcinoma following D2 radical surgery and DS (Docetaxel + S-1) adjuvant chemotherapy. All participants will undergo D2 radical surgery, receive six cycles of DS chemotherapy, and then continue with S-1 chemotherapy for up to one year post-operation. The study is designed as a single-arm trial, focusing on the outcomes of this treatment regimen.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with histologically confirmed locally advanced gastric adenocarcinoma who have undergone D2 radical surgery.

Not a fit: Patients with other types of tumors, significant tumor recurrence, or those who are pregnant or nursing may not benefit from this study.

Why it matters

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

How similar studies have performed: While there have been studies on adjuvant therapies for gastric cancer, the specific sequential use of S-1 following DS chemotherapy is a novel approach.

Eligibility criteria

Inclusion Criteria:

* (1) Histologically or cytologically confirmed adenocarcinoma of the stomach or adenocarcinoma of the gastroesophageal junction;
* (2) Radical surgery (D2 lymph node dissection) for gastric cancer in our center, with postoperative pathological stage of stage III;
* (3) No significant tumor recurrence or metastasis as assessed by imaging;
* (4) Age 18 years - 75 years;
* (5) ECOG score of 0 or 1;
* (6) Laboratory tests tolerant to chemotherapy;
* (7) Hematological examination: no obvious signs of hematologic diseases, ANC ≥ 1.5 × 10\^9/L, platelet count ≥ 80 × 10\^9/L, Hb ≥ 90 g/L, WBC ≥ 3.0 × 10\^9/L before enrollment, and no bleeding tendency; (8) Biochemical examination: total bilirubin \< 1.5 times the upper limit of normal value, AST, ALT \< 2.5 times the upper limit of normal value, creatinine \< 1.5 times the upper limit of normal value.

Exclusion Criteria:

* (1) Other pathological types of tumors;
* (2) Pregnant or nursing women;
* (3) Those with a history of other malignant neoplastic disease in the last 5 years;
* (4) Those with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder, where the investigator determines whether the clinical severity prevents signing an informed consent form or affects the patient's compliance with oral medications;
* (5) Clinically severe (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or arrhythmias requiring pharmacologic intervention, or a history of myocardial infarction within the last 12 months;
* (6) Severe diabetes-related complications, such as diabetic nephropathy, diabetic ketosis, etc;
* (7) Those with digestive tract obstruction or physiological abnormalities, or suffering from malabsorption syndrome, which may affect S-1 absorption;
* (8) Those who have had gastrointestinal bleeding in the last two weeks, or are at high risk of bleeding as judged by the investigator;
* (9) Known to have peripheral nerve disease ≥ NCI-CTC AE grade 1. but with deep tendon reflexes (DTR) only;
* (10) Those requiring immunosuppressive therapy for organ transplantation;
* (11) who have received other chemotherapy regimens
* (12) Those with uncontrolled severe infections, or other serious concomitant diseases;
* (13) Allergic to S-1 or any of the study drug components.

Where this trial is running

Hanzhou, Zhejiang

• Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University — Hanzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Xiaoli Jin

Conditions: Locally Advanced Gastric Adenocarcinoma, Chemotherapy Effect