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

NCT ID: NCT05813015

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-28
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Locally Advanced Gastric Adenocarcinoma; Chemotherapy Effect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Docetaxel 40mg/m2，every 21 days，6 cycles.

Tegafur-Gimeracil-Oteracil

Intervention Type: DRUG

S-1 40-60mg/m2，p.o, BID, day 1-14, till 1 year postoperation.

Interventions

Docetaxel

Docetaxel 40mg/m2，every 21 days，6 cycles.

Intervention Type: DRUG

Tegafur-Gimeracil-Oteracil

S-1 40-60mg/m2，p.o, BID, day 1-14, till 1 year postoperation.

Intervention Type: DRUG

Other Intervention Names

S-1

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Jian Chen

head of Gastrointestinal department of second affiliated hospital of Zhejiang University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University

Hanzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoli Jin

Role: CONTACT

Jinxiaoli@zju.edu.cn

+86-13605809870

Facility Contacts

Xiaoli Jin, Doctor

Role: primary

Jinxiaoli@zju.edu.cn

86-13605809870

Other Identifiers

ZRWC_GC_C001

Identifier Type: -

Identifier Source: org_study_id