Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT05813015

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

Led by Zhejiang University · Updated on 2023-04-14

70

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
  • Completed D2 radical lymph node dissection surgery for gastric cancer at the study center, with postoperative stage III
  • No significant tumor recurrence or metastasis on imaging
  • Aged between 18 and 75 years
  • ECOG performance score of 0 or 1
  • Laboratory results show tolerance to chemotherapy
  • Hematological exams show ANC ≥ 1.5 x 10^9/L, platelet count ≥ 80 x 10^9/L, hemoglobin ≥ 90 g/L, WBC ≥ 3.0 x 10^9/L, and no bleeding tendency
  • Biochemical tests with total bilirubin less than 1.5 times normal, AST and ALT less than 2.5 times normal, creatinine less than 1.5 times normal
Not Eligible

You will not qualify if you...

  • Other types of tumors besides adenocarcinoma
  • Pregnant or breastfeeding women
  • History of other cancers within the past 5 years
  • History of uncontrolled epilepsy, central nervous system disorder, or psychiatric disease affecting consent or medication compliance
  • Severe heart conditions such as symptomatic coronary artery disease, NYHA class II or worse heart failure, arrhythmias requiring treatment, or recent heart attack within 12 months
  • Severe diabetes complications like nephropathy or ketosis
  • Digestive tract obstruction or malabsorption syndromes affecting drug absorption
  • Gastrointestinal bleeding within the last two weeks or high bleeding risk
  • Peripheral nerve disease at grade 1 or higher with deep tendon reflexes
  • Need for immunosuppressive therapy for organ transplant
  • Previous use of other chemotherapy regimens
  • Uncontrolled serious infections or other major illnesses
  • Allergic to S-1 or any study drug components

AI-Screening

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Trial Site Locations

Total: 1 location

1

Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University

Hanzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

X

Xiaoli Jin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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