Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT07366528

Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer

Led by Ruijin Hospital · Updated on 2026-01-26

387

Participants Needed

5

Research Sites

254 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a multicenter, open-label, phase 3, randomized, non-inferiority study aimed to investigate the effect on disease-free survival of adjuvant chemotherapy with oxaliplatin plus S-1 compared with adjuvant chemotherapy with docetaxel plus S-1 after D2 gastrectomy in patients with stage III gastric cancer.

CONDITIONS

Official Title

Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years old, male or female
  • Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
  • Underwent standard D2 gastrectomy with complete tumor removal (R0 resection) and no prior systemic therapy
  • Pathological stage IIIA, IIIB, or IIIC gastric cancer with Lauren classification
  • No evidence of metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  • Adequate organ function: ANC ≥1.5x10^9/L, white blood count ≥3.5x10^9/L, platelets ≥75x10^9/L, hemoglobin ≥80 g/L, ALT/AST ≤2.5 times upper limit of normal (≤5 times if liver metastasis), serum bilirubin ≤1.5 times upper limit, serum creatinine ≤1.5 times upper limit
  • Women of childbearing potential must use contraception starting at least one month before screening and throughout the study and specified post-study period
  • Signed informed consent and willingness to follow study procedures
Not Eligible

You will not qualify if you...

  • Presence of other primary cancers except cured skin tumors or cervical carcinoma in situ
  • Severe complications likely to limit survival to less than 5 years
  • Uncontrolled comorbidities such as infections, hypertension, diabetes, or heart disease
  • Allergy to study medications
  • Conditions affecting ability to take oral medication such as bowel obstruction
  • Organ function inadequate to tolerate study treatment
  • Any other condition making the patient unsuitable for the study as judged by investigators

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 5 locations

1

Yuebei People's Hospital

Shaoguan, Guandong, China

Not Yet Recruiting

2

Fudan University Shanghai Cancer Center

Shanghai, China

Not Yet Recruiting

3

Renji Hospital

Shanghai, China

Not Yet Recruiting

4

Ruijin Hospital

Shanghai, China

Actively Recruiting

5

Shanghai Tenth People's Hospital

Shanghai, China

Not Yet Recruiting

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Research Team

C

Chenfei Zhou, MD, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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