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NCT Number: NCT05813015

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University

Hanzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Xiaoli Jin, Doctor

CONTACT

[email protected]

86-13605809870

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

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

Tegafur-Gimeracil-Oteracil

Drug

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

Other names: S-1

Primary outcomes

  1. Recurrence free survival

    Time frame: 3 years

    Recurrence free survival

Secondary outcomes

  1. Overall survival

    Time frame: up to 5 years

    Overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoli Jin

CONTACT

[email protected]

+86-13605809870

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2023
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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