Study of Comparing of With and Without Sequential Therapy of S-1

Trial Title: Study of Comparing of With and Without Sequential Therapy of S-1

NCT ID: NCT05813015

Condition: Locally Advanced Gastric Adenocarcinoma
Chemotherapy Effect

Conditions: Official terms:
Adenocarcinoma
Docetaxel
Tegafur

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Docetaxel
Description: Docetaxel 40mg/m2，every 21 days，6 cycles.
Arm group label: DS-S group

Intervention type: Drug
Intervention name: Tegafur-Gimeracil-Oteracil
Description: S-1 40-60mg/m2，p.o, BID, day 1-14, till 1 year postoperation.
Arm group label: DS-S group

Other name: S-1

Summary: The goal of this single arm clinical trial is to learn about sequential S-1 adjuvant therapy in patient wich locally advanced gastric cancer. The main question it aims to answer is: • The efficacy and safety of S-1 adjuvant therapy, following D2 radical surgery and DS(Docetaxel + S-1) adjuvant chemotherapy. All patients with locally advanced gastric cancer will received D2 radical surgery, 6 cycles of DS chemotherapy, and sequential S-1 chemotherapy up to 1 year postoperation.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University

Address:
City: Hanzhou
Zip: 310000
Country: China

Status: Recruiting

Contact:
Last name: Xiaoli Jin, Doctor

Phone: 86-13605809870
Email: Jinxiaoli@zju.edu.cn

Start date: January 28, 2023

Completion date: December 31, 2026

Lead sponsor:
Agency: Zhejiang University
Agency class: Other

Source: Zhejiang University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05813015