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

NCT05813015 | Recruiting Phase 3

• 1 other identifier: ZRWC_GC_C001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Recurrence free survival

  Recurrence free survival

  3 years

Secondary Outcomes (1)

• Overall survival

  up to 5 years

Study Arms (1)

DS-S group

EXPERIMENTAL

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; Drug: Tegafur-Gimeracil-Oteracil

Interventions

Docetaxel DRUG

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

DS-S group

Tegafur-Gimeracil-Oteracil DRUG

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

Also known as: S-1

DS-S group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University

Hanzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

Docetaxel; tegafur-gimeracil-oteracil; S 1 (combination)

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Xiaoli Jin

CONTACT

+86-13605809870; Jinxiaoli@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of Gastrointestinal department of second affiliated hospital of Zhejiang University

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: April 14, 2023
• Study Start: January 28, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

CN (1)