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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy Effect; Locally Advanced Gastric Adenocarcinoma
• Intervention / Treatment: Drug: Docetaxel; Drug: Tegafur-Gimeracil-Oteracil

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xiaoli Jin; Phone Number: +86-13605809870; Email: Jinxiaoli@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hanzhou, Zhejiang, China, 310000
      • Recruiting
      • Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University
      • Contact: Xiaoli Jin, doctor; Phone Number: 86-13605809870; Email: Jinxiaoli@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DS-S group; All patients pathologically confirmed pTNM stage III, will receive 6 cycles of DS chemotherapy, and sequential S-1 chemotherapy till 1 year postoperation.	Drug: Docetaxel; Docetaxel 40mg/m2，every 21 days，6 cycles.; Drug: Tegafur-Gimeracil-Oteracil; S-1 40-60mg/m2，p.o, BID, day 1-14, till 1 year postoperation.; Other Names: S-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence free survival	Recurrence free survival	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	up to 5 years

Collaborators and Investigators

• Sponsor: Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2023
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: April 2, 2023
• First Submitted That Met QC Criteria: April 2, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Tegafur
• Other Study ID Numbers: ZRWC_GC_C001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No