RecruitingPhase 3NCT07366528

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

Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer After D2 Gastrectomy (DRAGON-Adjuvant): a Multicenter, Open-label, Phase 3, Randomized, Non-inferiority Study

Sponsor

Ruijin Hospital

Enrollment

387 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer (GC)Adjuvant Chemotherapy Oxaliplatin Stage 3 Cancer Docetaxel

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria9

age 18 to 80 years old, male and female
histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
patients underwent standard D2 gastrectomy and achieved R0 resection, and had no systemic therapy like neoadjuvant therapy
American Joint Committee on Cancer stage IIIA (T2N3a, T3N2, T4aN1, T4aN2, T4bN0), IIIB (T1N3b, T2N3b, T3N3a, T4aN3a, T4bN1, T4bN2), IIIC (T3N3b, T4aN3b, T4bN3a, T4bN3b), and has Lauren classification
with no evidence of metastatic disease
ECOG 0 to 1
Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥80g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
Woman of childbearing age should contracept for at least one month before screening and commit to using contraception throughout the entire study period and for the specified time after the study ends.
Signed informed consent and willing to follow the study protocol

Exclusion Criteria7

other primary malignancies, except for cured skin tumors or cervical carcinoma in situ
severe complications that may lead to an expected survival time less than 5 years
uncontrollable comorbidities, such as infectious disease, chronic diseases like hypertension, diabetes, heart diseases.
allergic to study medication
bowel obstruction or other conditions affecting oral administration
organ functions that cannot tolerate study treatment
other conditions that patients are unsuitable for this study assessed by the investigators

Interventions

DRUGOxaliplatin plus S-1

SOX group: eight 3-week cycles of intravenous oxaliplatin (130mg/m2 on day 1 for each cycle) with orally S-1 dose dependent on body surface area (\<1.24 m2, 40mg twice a day; 1.25-1.5 m2, 50mg twice a day; \>1.5m2 60mg twice a day, days 1 to 14 of each cycle).

DRUGDocetaxel plus S-1

DS group: S-1 on days 1 to 14 of a 3-week cycle during the first cycle. During the second to seventh cycles, patients received intravenous infusion of docetaxel (40mg/m2) on day 1 of each cycle and S-1 on days 1 to 14 of a 3-week cycle. After the eighth cycle, treatment with S-1 continued on days 1 to 28 of 6-week cycles for up to 1 year.