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Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 80

Comparing oxaliplatin plus S-1 versus docetaxel plus S-1 after surgery for stage III stomach cancer

Official title: 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

Run by Ruijin Hospital · NCT07366528 · Data updated 2026-11-12

This trial tests whether oxaliplatin plus S-1 or docetaxel plus S-1 is better at preventing cancer recurrence in people with stage III gastric cancer after D2 gastrectomy.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment387 (estimated)
SponsorRuijin Hospital
Academic / other
Drugs / interventionschemotherapy
Locations5 sites (Shaoguan, Guandong and 4 other locations)
StatusRecruiting
StartedDecember 15, 2025
Main results expectedOctober 30, 2028
Study endsOctober 31, 2030
Registry record updatedJanuary 26, 2026
Trial IDNCT07366528 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–80 years old with histologically confirmed stage III gastric or gastroesophageal junction adenocarcinoma who had D2 gastrectomy with R0 resection, ECOG 0–1, no prior systemic therapy, no metastases, and adequate organ function are ideal candidates.

Probably not a fit

Patients with metastatic disease, prior neoadjuvant systemic therapy, poor performance status (ECOG >1), significant organ dysfunction, or non-stage III disease are unlikely to benefit from this adjuvant comparison.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, randomized non-inferiority phase 3 trial enrolling patients with pathological stage III gastric or gastroesophageal junction adenocarcinoma who underwent D2 gastrectomy with R0 resection. Participants are randomly assigned to receive either oxaliplatin plus oral S-1 (SOX) or docetaxel plus oral S-1 (DS) as adjuvant chemotherapy, following the dosing schedules used in prior trials. The primary endpoint is disease-free survival, with safety and tolerability compared between regimens, paying attention to oxaliplatin-related neuropathy and the longer S-1 exposure in the DS arm. Regular clinic visits are required for intravenous infusions, oral drug monitoring, and follow-up imaging.

Why it matters

Potential benefit: If successful, the trial could identify an adjuvant regimen that provides similar cancer control with a preferable side-effect profile or shorter treatment duration, helping patients and doctors choose the best option.

How similar studies have gone: Previous trials (RESOLVE and JACCRO GC-07) supported the use of SOX and DS individually as adjuvant options, but a direct head-to-head comparison like this is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. age 18 to 80 years old, male and female
2. histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
3. patients underwent standard D2 gastrectomy and achieved R0 resection, and had no systemic therapy like neoadjuvant therapy
4. 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
5. with no evidence of metastatic disease
6. ECOG 0 to 1
7. 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.
8. 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.
9. Signed informed consent and willing to follow the study protocol

Exclusion Criteria:

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

Where it's running

  • Ruijin Hospital
    Shanghai, China     Recruiting
  • Yuebei People's Hospital
    Shaoguan, Guandong, China     Not yet recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, China     Not yet recruiting
  • Renji Hospital
    Shanghai, China     Not yet recruiting
  • Shanghai Tenth People's Hospital
    Shanghai, China     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Gastric Cancer (GC) 30Adjuvant Chemotherapy 6Docetaxel 2Oxaliplatin 3Ruijin Hospital 182
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.